FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX-EMS DEFIBRILLATOR
MDR report key: 2250948
·
Received August 31, 2011
Report
- Report Number
- 1218950-2011-02590
- Event Type
- Malfunction
- Date Received
- August 31, 2011
- Report Date
- August 4, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THE UNIT HAD NO DISPLAY. THERE WAS NO REPORTED PATIENT INVOLVEMENT. PHILIPS FSE EVALUATED THE DEVICE AND CONFIRMED THE COMPLAINT. THE FIELD SERVICE ENGINEER REPLACED THE POWER PCA TO RESOLVE THE PROBLEM. THE DEVICE PASSED ALL TESTS AND WAS PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE UNIT HAD NO DISPLAY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
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 |