MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-04-11 for SONICAID FM830ENCORE manufactured by Huntleigh Healthcare Ltd. Diagnostics.
[16432265]
Client was using an (b)(4) to monitor a woman. When the analysis was printed the stv value was zero and the clinician made the decision to perform a cesarean section. The baby was born with no apparent problems. Mfr ref number 1000589001-2013-00003.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419652-2013-00093 |
| MDR Report Key | 3110558 |
| Report Source | 99 |
| Date Received | 2013-04-11 |
| Date of Report | 2013-03-20 |
| Date of Event | 2013-03-19 |
| Date Facility Aware | 2013-03-20 |
| Report Date | 2013-04-10 |
| Date Reported to FDA | 2013-04-10 |
| Date Reported to Mfgr | 2013-04-10 |
| Date Added to Maude | 2013-05-15 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONICAID |
| Generic Name | FM800 RANGE OF FETAL MONITORS |
| Product Code | HEL |
| Date Received | 2013-04-11 |
| Model Number | FM830ENCORE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS |
| Manufacturer Address | 35 PORTMANMOOR ROAD CARDIFF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-11 |