FDA Adverse Event
Injury
Summary report: N
HEARTSTART MRX
MDR report key: 6092181
·
Received November 8, 2016
Report
- Report Number
- MW5065935
- Event Type
- Injury
- Date Received
- November 8, 2016
- Date of Event
- November 2, 2016
- Report Date
- November 8, 2016
- Manufacturer
- PHILLIPS
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
DEFIBRILLATION CABLES / PADS FAILED DURING CARDIAC ARREST. SECOND CARDIAC MONITOR HAD TO BE USED. PHILLIPS MRX HEARTSTART MONITOR. SERIAL NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739090 | HEARTSTART MRX | MRX4 | MKJ | PHILLIPS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Life Threatening |