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 2011-05-16 for FETAL MONITOR M1351A manufactured by Philips Medical Systems.
[2002282]
The customer reported that a patient experienced an hypoxic-ischaemic event during the intra-partum period and resuscitation incident involving a philips fetal monitor.
Patient Sequence No: 1, Text Type: D, B5
[9071301]
(b)(4). The customer reported that a patient experienced an hypoxic-ischaemic event during the intra-partum period and resuscitation incident involving a philips fetal monitor. There is an allegation of permanent central nervous system (cns) injury to the child, but there is no allegation of any role of the monitor in causing or contributing to the event or outcome. Philips is in the process of obtaining additional information regarding this incident 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 | 9610816-2011-00256 |
| MDR Report Key | 2098537 |
| Report Source | 05,06,07 |
| Date Received | 2011-05-16 |
| Date of Report | 2011-04-27 |
| Date Mfgr Received | 2011-04-27 |
| Date Added to Maude | 2011-05-24 |
| 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 ATAIDE |
| 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 | 2011-05-16 |
| 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 | 1. Required No Informationntervention | 2011-05-16 |