MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-25 for OXIFIRST * manufactured by Mallinckrodt Inc. Healthy Mother And Baby Div.
[20138070]
Dr was using the nellcor n-400 fetal oxygen saturation monitoring system on a pt who was having repetitive severe variable decelerations. The resident on labor placed the nellcor n-400 monitoring device for add'l info. The pt continued to have repetitive severe variable decelerations, however they were reassured by the fetal oximetry results (> 50). When the pt became completely dilated, they started pushing. The variables became worse but the fetal oxygen saturation monitor continued to give reassuring results (>50). Dr delivered the pt with a vacuum extractor without difficulty. The pt had very low apgar scores; 1, 5, 5 at 1 min, 5 mins and 10 mins, respectively. The pt required assisted ventilation with bag and mask and was eventually intubated for mechanical ventilation. The pt was delivered approx 10 mins following a fetal oxygen saturation reading of 58. Dr wants to make the fda aware of this outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024893 |
| MDR Report Key | 392119 |
| Date Received | 2002-04-25 |
| Date of Report | 2002-04-25 |
| Date of Event | 2002-04-25 |
| Date Added to Maude | 2002-05-08 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIFIRST |
| Generic Name | N-400 FETAL OXYGEN SATURATION SYSTEM |
| Product Code | MMA |
| Date Received | 2002-04-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 381148 |
| Manufacturer | MALLINCKRODT INC. HEALTHY MOTHER AND BABY DIV |
| Manufacturer Address | 4280 HACIENDA DR PLEASANTON CA 94588 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Life Threatening | 2002-04-25 |