MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-01-24 for FETAX OXYGEN SENSOR FS-14 * manufactured by Nellcor Puritan Bennett.
[19152409]
According to the hospital, an n400 fetal oxygen saturation monitoring system was providing fetal heart tones when they performed the c-section on the mother. The baby was stillborn. Nellcor puritan bennett has requested add'l info and the strip for review but none has been provided. The hospital requested add'l education and training. A follow-up education has been provided to the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025525-2001-00007 |
| MDR Report Key | 372608 |
| Report Source | 07 |
| Date Received | 2002-01-24 |
| Date of Report | 2001-11-30 |
| Report Date | 2001-11-30 |
| Date Mfgr Received | 2001-11-02 |
| Date Added to Maude | 2002-01-24 |
| 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 | 3 |
| Manufacturer Contact | JULIE MALLETT |
| Manufacturer Street | 2200 FARADAY AVE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7606035800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETAX OXYGEN SENSOR FS-14 |
| Generic Name | FETAL OXYGEN SENSOR |
| Product Code | MMA |
| Date Received | 2002-01-24 |
| Model Number | FS-14 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 361733 |
| Manufacturer | NELLCOR PURITAN BENNETT |
| Manufacturer Address | 2200 FARADAY AVENUE CARLSBAD CA 92008 US |
| Baseline Brand Name | FETAX OXYGEN SENSOR FS-14 |
| Baseline Generic Name | FETAL OXYGEN SENSOR |
| Baseline Model No | FS-14 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2002-01-24 |