FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 3060889
·
Received March 26, 2013
Report
- Report Number
- 1218950-2013-01023
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Report Date
- March 7, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY DURING USE. SHOCKS WERE ATTEMPTED BUT ABORTED. THE INVOLVED PT DIED; THE DEATH IS REPORTED IN MDR# 1218950-2013-01022. THE CUSTOMER BELIEVES THAT THE DEVICE FAILED. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY DURING USE. SHOCKS WERE ATTEMPTED BUT ABORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123047 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |