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 2010-05-20 for FETAL MONITOR M1351A manufactured by Philips Medical Systems.
[1499660]
The customer reported that when they connected the mother to the monitor, they were receiving traces even though they were aware that the baby had died at least 24 hours before the monitoring began.
Patient Sequence No: 1, Text Type: D, B5
[8627778]
The customer reported that when thy connected the mother to the monitor; they were receiving traces even though they were aware that the baby had previously died. The initial info is most consistent with monitoring the mother instead of the baby. Product labeling (instructions for use) adequately describes verification of fetal viability before monitoring and differentiation between the mother's heart rate (hr) and the baby's hr. Philips is in the process of obtaining add'l 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 | 9610816-2010-00163 |
| MDR Report Key | 1697304 |
| Report Source | 05,06,07 |
| Date Received | 2010-05-20 |
| Date of Report | 2010-05-18 |
| Date Mfgr Received | 2010-05-18 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2010-05-26 |
| 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 RD |
| 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 |
| Product Code | HFM |
| Date Received | 2010-05-20 |
| 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 | HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-05-20 |