FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX -EMX DEFIBRILLATOR
MDR report key: 4532322
·
Received January 12, 2015
Report
- Report Number
- 1218950-2015-00807
- Event Type
- Malfunction
- Date Received
- January 12, 2015
- Report Date
- January 26, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS THAT THE BATTERY PINS WERE LOOSE IN BOTH SLOTS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25113 | HEARTSTART MRX -EMX DEFIBRILLATOR | DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |