MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-10-29 for FETALGARD 3000 IP10-E-104 UNK manufactured by Analogic Corporation.
[20192244]
An infant was still-born while the mother was being monitored by the device (fetalgard 3000 monitor), and additionally by a watchchild monitoring system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219601-1997-00001 |
| MDR Report Key | 128911 |
| Report Source | 07 |
| Date Received | 1997-10-29 |
| Date of Report | 1997-10-03 |
| Date of Event | 1997-10-02 |
| Date Mfgr Received | 1997-10-02 |
| Device Manufacturer Date | 1995-07-01 |
| Date Added to Maude | 1997-10-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETALGARD 3000 |
| Generic Name | FETAL MONITOR |
| Product Code | KXN |
| Date Received | 1997-10-29 |
| Model Number | IP10-E-104 |
| Catalog Number | UNK |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 126098 |
| Manufacturer | ANALOGIC CORPORATION |
| Manufacturer Address | 360 AUDUBON RD. WAKEFIELD MA 01880 US |
| Baseline Brand Name | FETALGUARD 3000 |
| Baseline Generic Name | FETAL MONITOR |
| Baseline Model No | IP10-E-104 |
| Baseline Catalog No | UNK |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-29 |