FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX -EMS DEFIBRILLATOR
MDR report key: 3905159
·
Received June 10, 2014
Report
- Report Number
- 1218950-2014-03236
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Report Date
- May 15, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED "B" SIDE BATTERY SLOT IS OUT OF SERVICE. FULLY CHARGED NOT READING FULL IN MONITOR. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340354 | HEARTSTART MRX -EMS DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |