MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2002-09-20 for OXIFIRST FETAL OXYGEN SATURATION MONITOR N-400 N400USA manufactured by Nellcor Puritan Bennett.
[21383971]
Facility reported that during a complicated delivery, the last fspo2 reading 34 minutes before delivery was 37%. Patient apgar scores were 1, 3, and 6 at time of birth. The patient was transferred to the neonatal intensive care unit, and is expected to be fine. The chief obstetrician for the facility acknowledged that there were errors in the resuscitation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025525-2002-00027 |
| MDR Report Key | 417828 |
| Report Source | 05,06,07 |
| Date Received | 2002-09-20 |
| Date of Report | 2002-09-20 |
| Date of Event | 2002-08-22 |
| Date Mfgr Received | 2002-08-23 |
| Date Added to Maude | 2002-09-24 |
| 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 | 0 |
| Manufacturer Contact | JAMES GARVEY II |
| Manufacturer Street | 4280 HACIENDA DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9254634479 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIFIRST FETAL OXYGEN SATURATION MONITOR |
| Generic Name | FETAL PULSE OXIMETER |
| Product Code | MMA |
| Date Received | 2002-09-20 |
| Model Number | N-400 |
| Catalog Number | N400USA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 406862 |
| Manufacturer | NELLCOR PURITAN BENNETT |
| Manufacturer Address | 4280 HACIENDA DRIVE PLEASANTON CA 94588 US |
| Baseline Brand Name | OXFIRST FETAL OXYGEN SATURATION MONITOR |
| Baseline Generic Name | FETAL PULSE OXIMETER |
| Baseline Model No | N-400 |
| Baseline Catalog No | N400USA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-09-20 |