FDA Adverse Event
Malfunction
Summary report: N
PHILIPS MEDIZIN SYSTEMS MONITORING DEVICE - ARTERIAL LINE
MDR report key: 8231463
·
Received January 8, 2019
Report
- Report Number
- MW5082976
- Event Type
- Malfunction
- Date Received
- January 8, 2019
- Date of Event
- December 19, 2018
- Report Date
- January 3, 2019
- Manufacturer
- PHILIPS - BOBLINGEN GMBH
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PHILIPS MEDIZIN SYSTEMS MODULE - ARTERIAL LINE MODULE WOULD NOT WORK. THIS MODULE IS A PIECE OF THE MONITOR. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17872 | PHILIPS MEDIZIN SYSTEMS MONITORING DEVICE - ARTERIAL LINE | MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | PHILIPS - BOBLINGEN GMBH | M1006B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |