FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 4182146
·
Received August 4, 2014
Report
- Report Number
- 1218950-2014-04531
- Event Type
- Malfunction
- Date Received
- August 4, 2014
- Report Date
- July 9, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PR# (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE DEVICE HAD A RED X, CHIRP, AND DEVICE ERROR SERVICE REQUIRED MESSAGE, ALONG WITH ECG BIAS ERRORS IN THE DEVICE LOGS. THE DEVICE DISPLAYED AN ECG EQUIP MALFUNCTION INOP MESSAGE. THERE WAS NO REPORTED PT INVOLVEMENT OR NEGATIVE PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 452676 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |