MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-06-16 for PERITRONICS R486SX254F * manufactured by Life Serve Technologies.
[16271315]
Peritronics fetal monitor system at desk area did not register tracing. When temporarly fixed to provide tracing, alarms did not work. Extra staff needed to provide continual observation of system and intervention for fetal deceleration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 228073 |
| MDR Report Key | 228073 |
| Date Received | 1999-06-16 |
| Date of Report | 1999-05-21 |
| Date of Event | 1999-05-01 |
| Date Facility Aware | 1999-05-01 |
| Report Date | 1999-05-21 |
| Date Added to Maude | 1999-06-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERITRONICS |
| Generic Name | FETAL MONITOR DEVICE |
| Product Code | HEL |
| Date Received | 1999-06-16 |
| Model Number | R486SX254F |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 221162 |
| Manufacturer | LIFE SERVE TECHNOLOGIES |
| Manufacturer Address | 12910 AUTOMOBILE BLVD. CLEARWATER FL 33762 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-06-16 |