Hands-on MPR MeDCReSt

Are you the person in charge of handling MPR, such as submitting the report to MeDCReSt?

• Yes

• No

How long have you had experience managing MPR submissions?

• < 1 year

• 1-2 years

• more than 3 years

What is the requirement of Mandatory Problem Reporting in Act 737 & Medical Device (Duties and Obligations of Establishment) Regulation 2019?

• Section 40

  Regulation 5

• Section 40

  Regulation 7

• Section 41

  Regulation 3

• Section 41

  Regulation 6

Choose two forms involved in MPR.

• MPR form

• Patient form

• Investigation form

• Analysis form

Does the complaint that led to the incident should proceed with MPR?

• No

• Yes

Select the criteria of the incident where the reporting of MPR is not required.

• Deficiency of device found prior to its use

• Servicing issue

• Shelf-life or service life of medical devices exceeded

• Off-label use medical devices

 

The establishment A received an incident, but the information available is not enough. Does establishment A need to wait to report MPR until the information is enough?

 

• Yes

• No

The investigation report cannot be completed within the timeline. Do I have request the extension time before overdue or after overdue?

• Before overdue

• After overdue

The establishment received outside Malaysia incident. Does the incident needed to report to MDA?

• Need to report

• No need for reporting

How many extensions can be requested?

• Four

• Two

• Three