NOTE: after I sent this email..

Charles from FDA called me and he and I had hour and half long
conversation. After that he sent this letter.

---------- Forwarded message ----------

From: Madhuri <mcis99@gmail.com>
Date: Thu, Dec 12, 2013 at 8:49 PM
Subject: Fwd: information about GE Healthcare
To: james.woods@fda.hhs.gov

Respected James Woods,

I found your information on FDA website.

I wanted to share info about working at GEHC.

I am a lead engineer by profession. Background in electronics & communications engg, India. I have
masters degree in computer science from Cleveland state and post graduate management-economics
from India & system design from MIT(I haven't completed MIT course). I have extensive work experience
for designing and developing products and services for over 8 years now. I have worked on Genome
sequencing InVitro as well.

My point was:: Fixing defects are very early stage, doing proper design at the beginning/early stage is
better, because doing the same LATER ON..cost, time, efforts increase exponentially higher and puts lots
of consequences and ripple effects on the team, company, customers and stake holders.

Regards and thanks in advance for your time.

Madhuri Trivedi.

Ph: 4843629716-----------------------------------------------------------------

There were issues with product quality itself. Product Insite Exc was aging and dying with
almost disaster level situation (60000 medical devices communicate to this product/system.
) There were 2000-600 Defects in connectivity platform in production and some were
unresolved for almost ten years. I found out security issues /HIPPA issues.
Insite Exc(Insite Express Connect) product does not have a proper logging/audit trail/reporting available in
production environment. I confirmed it with Mike Walls.

HIPPA/HITECH law puts emphasis on audit trail/logging requirements.

HIPPA 164.312(b) Technical safeguards Standard: Audit controls Audit controls refer to the capability to
record and examine system activity.

And it's replacement project RSVP with GE intelligent platforms; failed after two years.The
previous connectivity model Insite Exc have performance and maintainability , quality,
security issues. This new connectivity model for the connectivity platforms by retaining
the existing agents at device side while upgrading the back office infrastructure.

When it occurred that "why we are still shipping defective InsiteExc product ; David Mehring manager replied
during a group meeting that "Connectivity is better than InsiteExc product" (means at least medical device will
have connectivity).

Customers have complained several times as InsiteExc product was not working and unavailable for more
than 23 times in a year.

---------- Forwarded message ----------

From: Madhuri <mcis99@gmail.com>
Date: Mon, Feb 10, 2014 at 10:07 AM
Subject: Re: information
To: "Myers, Charles F" <Charles.Myers@fda.hhs.gov>

Just thought to share this info. It shows recent activities ....My linkedin connection
shared it so I know about this.

Digital Attack Map

Top daily DDoS attacks worldwide

http://www.digitalattackmap.com/#anim=1&color=0&country=ALL&time=16066&view=m
ap

On Mon, Feb 10, 2014 at 11:44 AM, Myers, Charles

F <Charles.Myers@fda.hhs.gov> wrote:
Hello Madhuri,

The Acknowledgement letter will be sent to you soon.

Warm regards,
Charles

Charles F. Myers
FDA/CDRH/OIR/DRH
Phone: 301-796-5619
E-mail: Charles.Myers@fda.hhs.gov
From: Madhuri [mailto:mcis99@gmail.com]
Sent: Monday, February 10, 2014 12:00 PM
To: Myers, Charles F
Subject: Re: information

Respected Charles Myers,

The letter you mentioned; you will send regarding looking into the matter..
Just thought to mention my fax number.
Here is my Fax: 7087784859 .

Thanks and regards

Madhuri

On Fri, Jan 31, 2014 at 10:21 AM, Myers, Charles F <Charles.Myers@fda.hhs.gov> wrote:
Hello Madhuri Trivedi,

I will be available this afternoon after 3:00 PM (EST) for a short time. May I contact you then at the
number you provided below?

Warm regards,
Charles

Charles F. Myers
FDA/CDRH/OIR/DRH
Phone: 301-796-5619
E-mail: Charles.Myers@fda.hhs.gov
From: Madhuri [mailto:mcis99@gmail.com]
Sent: Friday, January 31, 2014 10:49 AM
To: Myers, Charles F
Subject: information

Respected Charles Myers,

I received your message on Jan 28.
What is the best time to talk briefly. I can be reached at 4843629716.

Regards and thanks

Madhuri Trivedi