FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 4251564
·
Received September 3, 2014
Report
- Report Number
- 1218950-2014-05294
- Event Type
- Malfunction
- Date Received
- September 3, 2014
- Report Date
- August 11, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE DEVICE'S STATUS LOG SHOWED AN ECG BIAS-PROCESSOR PCA ERROR. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535621 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |