FDA Adverse Event
Death
Summary report: N
HEARTSTART FRX
MDR report key: 6094512
·
Received November 10, 2016
Report
- Report Number
- 3030677-2016-02685
- Event Type
- Death
- Date Received
- November 10, 2016
- Date of Event
- October 26, 2016
- Report Date
- October 28, 2016
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 050004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UDI #: N/A .
Description of Event or Problem · 1
THE USER IS REPORTING THE DEVICE DID NOT SHOCK AS EXPECTED DURING A PATIENT RESCUE EVENT. THE DEVICE GAVE THE "REPLACE BATTERY" MESSAGE. THE PATIENT DID NOT SURVIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745932 | HEARTSTART FRX | AED | MKJ | PHILIPS MEDICAL SYSTEMS | 861304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |