MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-06 for FETAL HEART MONITOR M1350A * manufactured by Phillips Medical Systems.
[15379998]
Fetal heart monitor stopped recording fetal heart rate. External ultrasound monitor changed twice - continues to not record. Sent to bio for repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023285 |
| MDR Report Key | 359455 |
| Date Received | 2001-11-06 |
| Date of Report | 2001-10-29 |
| Date of Event | 2001-09-29 |
| Date Added to Maude | 2001-11-13 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETAL HEART MONITOR |
| Generic Name | FETAL HEART MONITOR |
| Product Code | KXN |
| Date Received | 2001-11-06 |
| Model Number | M1350A |
| Catalog Number | * |
| Lot Number | * |
| ID Number | TDI 91414 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 348633 |
| Manufacturer | PHILLIPS MEDICAL SYSTEMS |
| Manufacturer Address | 395 PAGE MILL RD PO BOX 10395 PALO ALTO CA 94303 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-11-06 |