MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-01 for 8040A manufactured by Hewlett-packard Gmbh.
[19160670]
Mother was admitted with contractions and put on the fetal monitor. A heart rate of approx 145 was being received via the us transducer. The pt at some point went to the bathroom and when she returned and was put back on the monitor, no heart rate could be found. Unknown measures were then taken by the nursing staff. The baby was delivered stillborn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951286-1996-90001 |
| MDR Report Key | 48497 |
| Date Received | 1996-11-11 |
| Date of Report | 1996-11-04 |
| Date of Event | 1996-09-21 |
| Date Facility Aware | 1996-10-23 |
| Report Date | 1996-11-04 |
| Date Added to Maude | 1996-11-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 8040A |
| Generic Name | CARDIOTOCOGRAPH |
| Product Code | KXN |
| Date Received | 1996-11-01 |
| Model Number | 8040A |
| Catalog Number | 8040A |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 49266 |
| Manufacturer | HEWLETT-PACKARD GMBH |
| Manufacturer Address | SCHICKARDSTRASSE 4 BOEBLINGEN GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1996-11-11 |