FDA Adverse Event
Malfunction
Summary report: N
FETAL MONITOR
MDR report key: 2595304
·
Received May 29, 2012
Report
- Report Number
- 9610816-2012-00252
- Event Type
- Malfunction
- Date Received
- May 29, 2012
- Report Date
- April 30, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- HFM
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THE M1351A FETAL MONITOR DISPLAYED ERROR 601 AFTER A FALL. THERE IS NOT SUFFICIENT INFO TO DETERMINE IF THIS MONITOR FELL FROM A MOUNT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE M1351A FETAL MONITOR DISPLAYED ERROR 601 AFTER A FALL. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FETAL MONITOR | HFM | PHILIPS MEDICAL SYSTEMS | M1351A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |