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 2002-12-13 for NELLCOR OXIFIRST FETAL PULSE OXIMETER N-400 N400USA manufactured by Nellcor Puritan Bennett.
[21956215]
During period of monitoring fsp02 reported to be within the range of 30-50% accompanied by decelerations. Fsp02 sensor was removed 8 minutes before delivery. Patient delivered with apgar of 5. It was also noted that the pt had shoulder dystocia and a nuchal cord x 1. The patient rapidly recovered with a 5 minute apgar of 7, and ten minute apgar of 8. The pt was discharged home for routine care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025525-2002-00042 |
| MDR Report Key | 433000 |
| Report Source | 05,06,07 |
| Date Received | 2002-12-13 |
| Date of Report | 2002-12-12 |
| Date of Event | 2002-11-13 |
| Date Mfgr Received | 2002-11-13 |
| Date Added to Maude | 2002-12-18 |
| 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 | NELLCOR OXIFIRST FETAL PULSE OXIMETER |
| Generic Name | FETAL PULSE OXIMETER |
| Product Code | MMA |
| Date Received | 2002-12-13 |
| Model Number | N-400 |
| Catalog Number | N400USA |
| Lot Number | * |
| 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 | 421958 |
| Manufacturer | NELLCOR PURITAN BENNETT |
| Manufacturer Address | 2200 FARADAY AVE. CARLSBAD CA 920087208 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 | 2002-12-13 |