MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-12-10 for FETAL MONITOR M1351A manufactured by Philips Medical Systems.
[3096053]
The customer reported bpm was under 80 and the alarms were not sounding. The baby was revived after birth and the baby is currently stable at the neonatal icu.
Patient Sequence No: 1, Text Type: D, B5
[10482494]
(b)(4). The customer reported bpm was under 80 and the alarms were not sounding. The baby was revived after birth and the baby is currently stable at the neonatal icu. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610816-2012-00496 |
| MDR Report Key | 2879057 |
| Report Source | 05,06,07 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-12-03 |
| Date Mfgr Received | 2012-12-03 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 2012-12-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENYSE MURPHY |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597844 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETAL MONITOR |
| Product Code | HFM |
| Date Received | 2012-12-10 |
| Model Number | M1351A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-10 |