# Question

1 Glass particles are found by the user in a contact lens vial… this ca
2 Removal of the medical device from market, is considered
3 In case of a Recall, what evidence of action taken should be provi
4 To ensure proper Medical devices disposal and avoid risks, applican
5 Wrong diagnosis or treatment should be reported to NHRA:
6 Room temperature, humidity and storage conditions may lead to an
7 Which of the following is Not a source of Field Safety Notices?
8 A patient dies after the use of a defibrillator, the defibrillator is w
9 What actions are usually recommended for Field Safety Corrective
10 Adverse event Are safety communications sent out by medical device
11 In case of a Recall, what evidence of action taken should be provi
12 What is the role of the supplier/authorized representative in handli
13 What is the maximum time frame for an authorized representative
14 End user acknowledgment is a document issued from …… stating rec
15 The field safety corrective action (FSCA) maybe spare parts replac
 Student Dashboard
A
Reported to NHRA
Recall
Invoice of destruction in Bahrain
NHRA approval
True
True
US. FDA
Should be reported to NHRA
Software update
True
Invoice of destruction in Bahrain
Inform NHRA
2 working days
Healthcare facility
True
 Student Dashboard
B
Not reported to NHRA
FSCA
Air way bill in case of return the defected medical device to the m
manufacturer approval
False
False
GHC
No need for reporting to NHRA
New instruction for use
False
Air way bill in case of return the defected medical device to the m
Inform end-user and ensure required action has been implemented
5 working days
Authorized Representative
False
C D

A or B None of the above

Supreme council of environment

Amazon ECRI

Spare part replacement All of the above

A or B None of the above

Provide required documents within the time frame All of the above
10 working days 1 month
Manufacturer
Correct Answer User Anwser Result
A A Correct
A A Correct
C C Correct
A A Correct
A A Correct
A A Correct
C C Correct
A A Correct
D D Correct
B B Correct
C C Correct
D D Correct
C C Correct
A A Correct
A A Correct