MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-02-07 for OXIFIRST FETAL OXYGEN SATURATION MONITORING SYST N400 * manufactured by Nellcor Puritan Bennett.
[16397631]
According to the hospital, an n400 fetal oxygen saturation monitoring system was providing spo2 readings in the 30-40% and disordered heart rate readings after an epidural was administered to the mother. The n400 system was removed 40 minutes prior to delivery. When the pt was delivered with forceps it was stillborn. A basic performance check on the fetal monitor was performed and found to work within specs. The fs14c sensor was discarded by the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025525-2002-00001 |
| MDR Report Key | 375445 |
| Report Source | 05,06 |
| Date Received | 2002-02-07 |
| Date of Report | 2002-01-08 |
| Date Mfgr Received | 2002-01-08 |
| Device Manufacturer Date | 1997-12-01 |
| Date Added to Maude | 2002-02-08 |
| 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 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIFIRST FETAL OXYGEN SATURATION MONITORING SYST |
| Generic Name | FETAL PULSE OXIMETER |
| Product Code | MMA |
| Date Received | 2002-02-07 |
| Model Number | N400 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 364552 |
| Manufacturer | NELLCOR PURITAN BENNETT |
| Manufacturer Address | 2200 FARADAY AVENUE CARLSBAD CA 92008 US |
| Baseline Brand Name | OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM |
| Baseline Generic Name | FETAL PULSE OXIMETER |
| Baseline Model No | N400 |
| Baseline Device Family | N400 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P9900 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2002-02-07 |