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..
[18336999]
Company received a report of patient born with poor apgar scores, acidosis, and possible seizures following labor with non-reassuring fhr, but with reassuring fspo2 values. A cesarean delivery was performed. Post delivery, the patient reportedly experienced seizures and was treated with phenobarbital and dilantin. Ct scan showed general edema with no evidence of ischemia. A follow up mri, was negative. The patient was subsequently weaned off medications and discharged for routine care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025525-2002-00030 |
| MDR Report Key | 423076 |
| Report Source | 05,06 |
| Date Received | 2002-10-21 |
| Date of Report | 2002-10-08 |
| Date of Event | 2001-07-01 |
| 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 | 412130 |
| 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 |