MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-21 for PHILIPS FETAL MONITOR M135OB manufactured by Philips Healthcare North America.
[20090424]
Pt was placed on fetal monitor when strip started showing that fetus was in distress. Pt was a planned c/s but due to the distress pt had stat c/s done. When monitor rechecked without being connected to anything, strip ran as if a fetus was in distress. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027029 |
| MDR Report Key | 2759860 |
| Date Received | 2012-09-21 |
| Date of Report | 2012-09-20 |
| Date of Event | 2012-07-10 |
| Date Added to Maude | 2012-09-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS FETAL MONITOR |
| Generic Name | FETAL MONITOR |
| Product Code | HFM |
| Date Received | 2012-09-21 |
| Model Number | M135OB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE NORTH AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-21 |