MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-10-21 for OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM N400 N400USA manufactured by Nellcor Puritan Bennett, Inc..
[15440341]
Company received a report of a patient who experienced neonatal depression and acidosis after reassuring saturations. Fspo2 readings were reported to be within 40-44%, nad no fhr abnormalities were observed with sensor placement. It was noted that during a period of non-reassuring fhr tracing, the fspo2 stopped tracing. Following a period of bradycardia, clinicians elected to perform cesarean section. No information was available for fhr for more than 25 minutes prior to delivery. Initial apgar score was reported to be zero. The patient was successfully resuscitated following birth, and has been discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025525-2002-00031 |
| MDR Report Key | 423086 |
| Report Source | 05,06 |
| Date Received | 2002-10-21 |
| Date of Report | 2002-10-08 |
| Date of Event | 2001-10-09 |
| Date Mfgr Received | 2001-10-09 |
| Date Added to Maude | 2002-10-23 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM |
| Generic Name | FETAL PULSE OXIMETER |
| Product Code | MMA |
| Date Received | 2002-10-21 |
| Model Number | N400 |
| Catalog Number | N400USA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 412140 |
| Manufacturer | NELLCOR PURITAN BENNETT, INC. |
| Manufacturer Address | 2200 FARADAY AVE. CARLSBAD CA 920087208 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. Hospitalization; 2. Required No Informationntervention | 2002-10-21 |