FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2113625
·
Received May 24, 2011
Report
- Report Number
- 1218950-2011-01448
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Report Date
- April 26, 2011
- Manufacturer
- PHILIPS MEDICAL
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- UNKNOWN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |