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 2010-06-16 for FETAL MONITOR SERIES 50 IP M1353A manufactured by Philips Medical Systems.
[22120737]
The customer reported that a death occurred while a pt was being monitored by a philips fetal monitor.
Patient Sequence No: 1, Text Type: D, B5
[22256249]
The customer reported that a death occurred while a pt was being monitored by a philips fetal monitor. The customer reported that the fetal monitor had given the baby's heart rate between 140 and 160bpm and then a range between 80bpm and 175bpm. Even when the baby was taken out of his mother, the monitor continued to show a rate of 140bpm whereas the baby was delivered stillborn. The available info is fully consistent with the clinicians monitoring the mother instead of the fetus. The available info is not sufficient to support that the use of the monitor was a factor in the stillbirth. Philips is in the process of obtaining additional info regarding this incident and the complaint is still under investigation. A final report will be submitted once the investigation is completed. (b) (4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610816-2010-00195 |
| MDR Report Key | 1729585 |
| Report Source | 05,06,07 |
| Date Received | 2010-06-16 |
| Date of Report | 2010-06-07 |
| Date of Event | 2010-06-05 |
| Date Mfgr Received | 2010-06-07 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2010-06-22 |
| 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 | NANCY SAYER |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETAL MONITOR SERIES 50 IP |
| Product Code | HFM |
| Date Received | 2010-06-16 |
| Model Number | M1353A |
| 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 | HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-06-16 |