MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-24 for AIRSHIELDS FETALGARD 3000 IP10-E-104 * manufactured by Analogic Corp/ Lifecare Group.
[87832]
A 37-yr-old presented to l+d for delivery. Originally using external monitor. After epidural placed attempted to use internal monitor. Could not obtain a good tracing and had to go back to using external monitor. Stillbirth resulted. Biomedical examined equipment & found: upon connection of ecg stimulator to the fecg scalp electrode adapter, whenever the fecg is stressed, the signal is lost or artifact produced. Crack in prongs of scalp electrode adapter. Equipment highly sensitive, picks up & produces tracings even when not connected to fetal scalp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 139827 |
| MDR Report Key | 139827 |
| Date Received | 1997-12-24 |
| Date of Report | 1997-12-22 |
| Date of Event | 1997-10-02 |
| Date Facility Aware | 1997-10-02 |
| Report Date | 1997-12-22 |
| Date Reported to Mfgr | 1997-12-23 |
| Date Added to Maude | 1997-12-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | AIRSHIELDS FETALGARD 3000 |
| Generic Name | FETAL MONITOR |
| Product Code | KXN |
| Date Received | 1997-12-24 |
| Model Number | IP10-E-104 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | CE-1937 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 136516 |
| Manufacturer | ANALOGIC CORP/ LIFECARE GROUP |
| Manufacturer Address | 360 AUDUBON RD WAKEFIELD MA 01880 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-12-24 |