FDA Adverse Event
Death
Summary report: N
HEARTSTART MRX
MDR report key: 3030502
·
Received March 26, 2013
Report
- Report Number
- 1218950-2013-01022
- Event Type
- Death
- Date Received
- March 26, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 7, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY DURING USE. THE INVOLVED PT DIED AND THE CUSTOMER BELIEVES THAT THE DEFIBRILLATOR FAILED. THIS COMPLAINT WILL REPORT THE DEATH. MDR#1218950-2013-01023 REPORTS THE FAULT DEFIBRILLATOR. 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. THE INVOLVED PT DIED AND THE CUSTOMER BELIEVES THAT THE DEFIBRILLATOR FAILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124577 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |