MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-08 for FETALGARD 3000 UNK manufactured by Analogic.
[101972]
An infant was stillborn and that the fetal monitor was indicating a heart rate. The value of the heart rate detected was not reported. The user has quarantined the monitor and will not yet allow the mfr to independently test and/or inspect the monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2510954-1997-00010 |
| MDR Report Key | 125541 |
| Date Received | 1997-10-08 |
| Date of Report | 1997-10-08 |
| Date of Event | 1997-10-01 |
| Date Facility Aware | 1997-10-02 |
| Report Date | 1997-10-08 |
| Date Reported to FDA | 1997-10-08 |
| Date Reported to Mfgr | 1997-10-08 |
| Date Added to Maude | 1997-10-14 |
| 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 | 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 | FETALGARD 3000 |
| Generic Name | FETAL MONITOR |
| Product Code | KXN |
| Date Received | 1997-10-08 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122889 |
| Manufacturer | ANALOGIC |
| Manufacturer Address | 360 AUDOBON RD WAKEFIELD MA 01880 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-10-08 |