FDA Adverse Event
Death
Summary report: N
HEARTSTART FRX
MDR report key: 2792394
·
Received October 4, 2012
Report
- Report Number
- 3030677-2012-01283
- Event Type
- Death
- Date Received
- October 4, 2012
- Report Date
- October 1, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 050004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD: ECG FROM DEPLOYMENT REVIEWED. RESULT: DEVICE CORRECTLY ANALYZED ECG AND ADVISED NO SHOCK DUE TO PRESENTING MORPHOLOGY. CONCLUSION: REPORTED DUE TO OUTCOME.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT DEVICE WAS DEPLOYED, HOWEVER, THE PT WAS NOT RESUSCITATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART FRX | MKJ | PHILIPS MEDICAL SYSTEMS | 861304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |