FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX -EMS DEFIBRILLATOR
MDR report key: 2142586
·
Received June 21, 2011
Report
- Report Number
- 1218950-2011-01765
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Report Date
- May 23, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO CHARGE AND SHOCK WHILE PERFORMING AN OP CHECK. THE DEVICE WAS EVALUATED AT PHILIPS. THE THERAPY PCA FAILED AUTO TEST AND RUN TIME FOR CHARGE AND SHOCK AS SEEN IN THE DUMP LOG. REPLACEMENT OF THE THERAPY PCA RESOLVED THE SYMPTOM. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO CHARGE AND SHOCK WHILE PERFORMING AN OP CHECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX -EMS DEFIBRILLATOR | MKJ | PHILIPS HEALTHCARE - ANDOVER | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |