FMI 36068 for CARESCAPE Monitor B850

software

Overview
This course is intended for Field Service Engineers (FSE).

In this course you will learn about FMI36068 for CARESCAPE

Monitor B850 software. This FMI will fix the following issues:
- Incorrect Cardiac Output value with a PDM or TRAM module
- ECG leads off alarm fails to activate in specific cases
Time: approximately 20 minutes to review
introductory presentation, as well as all of
the documentation involved.

After reviewing the presentation, you

must sign an acknowledgement of
receipt and understanding of the
information for the FMI.
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Learning objectives

Upon reviewing all of the documentation, you will be

able to:
 Explain the primary points of the FMI
 Identify the affected products
 Process an order for FMI Kits
 Describe the Service Request Opening and
Closure processes

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Contents

 Overview
 Lesson 1: Reasons for FMI
 Lesson 2: Service Requests (SR) and Ordering FMI Kits

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Reasons for FMI 36068 (Extract from the Customer Letter)

GE Healthcare has become aware of a potential safety issue associated with the
CARESCAPE Monitor B850 Cardiac Output measurement using Patient Data
Module (PDM) or TRAM Module, and activation of ECG Leads Off alarm in
specific cases.
1. When the CARESCAPE Monitor B850 is used to measure Cardiac Output values with
the Patient Data Module (PDM) Module or TRAM Module, Cardiac Output values
may be calculated incorrectly if the default catheter settings are used. This may lead
to improper treatment. However, with user-defined catheter settings, the values are
calculated correctly.

2. The ECG “Leads Off” alarm may not be activated with a specific user workflow. This
can happen in a workflow where the user chooses to Update Lead Set in the ECG
menu, but does not complete the ECG lead placement correctly. There will be a
message of “Lead Off” shown within the monitor ECG waveform display to inform
user of a missing lead. If the “Lead Off” error is not corrected and additional leads
are removed or become disconnected, a complete loss of ECG monitoring can occur
without activation of any “Leads Off” alarms.
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Systems Eligible for FMI 36068

FMI36068 affects all CARESCAPE Monitor B850 units

globally with a software level v1.0.6 or earlier. There are approximately 6914
All CARESCAPE Monitor B850 units operating software CARESCAPE Monitor B850
level v1.0.6 (or earlier) must be updated to v1.0.7. units affected:
The affected installed base of FMI36068 is in CliFS database
(link below). It can be found also in MyWorkshop,
DOC0940522.

CliFS database link:

http://clifs.health.ge.com/CliFS/fmiLogin.do?invoke=login

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The FMI kit FMI36068-001 (FMI CSCAPE B850

v1.0.7. Sw upgrade kit) contains
• 2044447-010 CD CSCAPE B850 v1.0.7

• 2052688-003 INSTR CSCAPE B850 FMI36068 ENG

• 2040384-108(F) INSTR INSTL CARESCAPE B850 SW RELOAD ENG

• 2040384-312 INSTR SVCE CSCAPE B850 TIME CONFIG ENG

• 2040384-XXX ADNDM OPR CARESCAPE B850 v1.0.5 (ENG, CZE, DAN, DUT,
FIN, GER, ITA, NOR, POL, POR, SPA, SWE, TUR, FRE ). - applies to v1.0.7 as well

• 2040387-001 CD OPR MNL CSCAPE B850 V1 MULTI

• 2040387-004 CD SVCE MNL CSCAPE B850 V1 ENG

The FMI Kit is NOT language specific

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Installation procedure for FMI36068

• The FMI Installation Instruction, 2052688-003, describes the overall

installation procedure of the FMI Kit.
• The SW installation instruction, 2040384-108F, describes the SW
installation procedure.

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** Special Notes Regarding the software installation **

FMI 36068 is a Mandatory Safety Recall.

The CARESCAPE Monitor B850 Software Installation Instructions (p/n

2040384-108F) must be followed. This is included in the FMI kit.
After the CARESCAPE Monitor B850 v1.0.7 software has been activated,
the Remove Inactive Software procedure MUST be performed.
Any previous version of CARESCAPE Monitor B850 software must be
removed from the monitor prior to placing the unit back into service.
Under no circumstances should old software remain on the
CARESCAPE Monitor B850.
This procedure must be followed to ensure old software cannot be re-
activated in the future.
NOTE: The software CD of this FMI kit can be left to the customer
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** Special Notes Regarding the enclosed manual addendum **

The FMI kit contains a manual addendum “CARESCAPE Monitor B850
Addendum for software version 1.0.5”.
• Provide this addendum for the clinical staff of the hospital.
Intended use of this addendum
This addendum must be used in conjunction with:
•“CARESCAPE Monitor B850 User’s Manual” for important safety information
and detailed instructions for clinical use of this product.
NOTE: Although the name of the addendum refers to v1.0.5 software, the
addendum applies as such also to the v1.0.7 software that is included In this
FMI kit.

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** Special Notes Regarding the enclosed manual addendum **

The FMI Kit includes User’s Manual CD (PN 2040387-001) and Technical Manual
CD (PN 2040387-004).
We recommend you to leave the manual CD’s to the customer, unless specifically
denied by the customer.

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Summary

 Overview
 Lesson 1: Reason for FMI
 Lesson 2: Service Requests (SR) and
Ordering FMI Kits

Lesson 1: Explained the reason for the FMI, as well as

which units are eligible for it.

FMI 36068
 FMI 36069 for CARESCAPE Monitor B650 software

Lesson 2

Service Requests (SR) and Ordering FMI Kits

This section will review the processes to:

• Open Service Requests
• Order FMI Kits
• Close the Service Requests upon completion

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Opening Service Requests

USA Service teams will have Service Requests (SR)

opened automatically; all other Service teams will need to
open Service requests according to their normal process
utilizing the Installed Base list released in CliFS.

For FMI 36068 Siebel SRs, the FMI field will denote
36068; the PO field will denote FMI36068 (no space).

The opening of SRs in Siebel will begin following the

launch of the FMI to Service. Service Requests outside of
Siebel should be opened when the Installed Base list is
Released in CliFS.

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Ordering FMI 36068 Kits

U.S.A.
• MS/DCAR FSEs to order FMI kits by e-mailing order form to
Key Points
FMI@ge.com  USA FSEs e-mail kit order form
• LSS/MIC FSEs are to order via LSS Customer Service (in to FMI@ge.com or LSS
order to be able to debrief).
Customer Service
Outside the U.S.A.
• Kits are to be ordered by Service Operations Manager/Service
Delivery Manager from FMI@ge.com or local system.  Outside the USA, Service
Operations Managers to order
The quantity of FMI Kits Needed: One (1) per SITE kits from FMI@ge.com or local
system
-can be left at site following completion of update.
 1 kit per site, plus each FSE
In addition, every affected FSE to have one (1) FMI Kit throughout the
duration of the FMI for ensure efficiency. keeps 1 kit with him/her

NOTE: FE shall offer customers one (1) manual addendum per each B850 monitor updated. Additional manual addendums
are available with one of the following methods:
1) Customer can order Manual CDs (including addendum) from CRC .
2) From GE Healthcare Common Document Library
http://olcweb.olc.med.ge.com:8020/servlet/ClientServletProp?REQ=Enter+Documentation+Library
3) From Clinical Systems InfoCenter
http://infocenter.health.ge.com/B/Marketing/FI3017d.nsf/Pages/Home
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Closing FMI Service Requests

All FMI SRs must be closed using appropriate

Status Code when complete.
FMI SR Resolution Choices
There are Status Codes to handle every situation, 1. Completed
such as: Update Installed, Unit not Found, and 2. FMI Not Required
Customer Refusal of Update. 3. Equipment in Storage/Not
Modified
It is important that all Service Requests are closed 4. Customer Refusal
to the correct Closure Code. This affects future 5. Equipment Cannot Be
actions as various GE databases are updated based Located
upon the closure code given for a serial number. 6. Customer Installed

** The due date for the FMI completion (F5) of all affected
B850 monitors is June 20, 2011 (FW25’11) **
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Closing FMI Service Requests

** Please Note Conditions Regarding
Closure Codes 4 and 5 **
If a Service Request for a serial number is closed FMI SR Resolution Choices
as Code 4 (Customer Refusal), the customer must 1. Completed
sign a Refusal form which is to be included in the 2. FMI Not Required
Service database 3. Equipment in Storage/Not
Modified
If Code 5 (Equipment Cannot Be Located) is 4. Customer Refusal
used, the appropriate Service database must 5. Equipment Cannot Be
document three (3) attempts to locate the serial Located
number, including name and position/title of the 6. Customer Installed
customer personnel involved

** The due date for the FMI completion (F5) of all affected
B850 monitors is June 20, 2011 (FW25’11) **
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Siebel FMI Fields

In Siebel, there are two (2) fields that must be completed correctly when
closing the SR.

One field is PO #. This field is found on the SERVICE REQUEST tab,

in the SR DETAILS column, near the bottom.
• Enter FMI36068

The other field needed is FMI #. This field is found on the OTHER
DETAILS tab, at the top of the MISC INFORMATION column.
• Enter 36068

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CliFS Accuracy is Vital

The CliFS Installed Base list plays an important role in many aspects of GE
Healthcare Systems information. One use is to provide input for future
possible field actions.

Because of the various uses, it is critical that the information provided in

CliFS (such as Customer name and address) at the completion of an FMI is
as accurate as possible.

In the USA, CliFS is updated from Siebel; therefore, please ensure all
information in Siebel is accurate.

Please ensure that the information in all databases (Service Requests, CliFS,
etc…) correctly reflects the latest information available.

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Summary
 Overview
 Lesson 1: Reason for FMI
 Lesson 2: Service Requests (SR) and Ordering FMI Kits
Lesson 2: You have just reviewed the processes used for
Opening Service Requests, Ordering FMI kits, and
Closing Service Requests.

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Index of FMI Documentation

Here is a listing of the various documents that are provided as separate hyperlinks to
MyWorkshop within the myLearning module:
• Customer Letter (DOC0934627): Released English Master of Customer Letter.
http://myworkshop.health.ge.com/ematrix/common/eLibDocument.jsp?type=type_
ControlledDocument&name=DOC0934627&rev=1
• Translated Customer Letter being sent to affected IB customers.
• Frequently Asked Questions document for FMI36068 (DOC0943822).
http://myworkshop.health.ge.com/ematrix/common/eLibDocument.jsp?type=type_
ControlledDocument&name=DOC0943822&rev=1
• FMI Release Notification/Bulletin (DOC0961150): Operational information and
Technical details regarding Service responsibilities for the FMI.
http://myworkshop.health.ge.com/ematrix/common/eLibDocument.jsp?
type=type_ControlledDocument&name=DOC0961150&rev=1

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Finish
You have successfully reviewed information regarding

FMI36068 for CARESCAPE Monitor B850 software:

- Incorrect Cardiac Output value with a PDM or TRAM module
- ECG leads off alarm fails to activate in specific cases

If you have any questions regarding the information within this course,
please contact your Service Manager.

FMI 36068