MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-02-14 for OXIFIRSTTM FETAL OXYGEN SATURATION MONITORING SYST N400 * manufactured by Nellcor Puritan Bennett.
[242196]
According to the hospital, an n400 fetal oxygen saturation monitoring system was providing sp02 readings in the 20-50%. The pt was admitted to the nicu and had a seizure within 24 hrs post delivery. A ct scan/mri was performed and hemorrhage was evident and brain changes were noted. The pt went home 6 days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025525-2002-00002 |
| MDR Report Key | 376598 |
| Report Source | 05,06 |
| Date Received | 2002-02-14 |
| Date of Report | 2002-01-16 |
| Date of Event | 2001-12-05 |
| Date Mfgr Received | 2002-01-16 |
| Device Manufacturer Date | 2001-02-01 |
| Date Added to Maude | 2002-02-15 |
| 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 | 7606035300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIFIRSTTM FETAL OXYGEN SATURATION MONITORING SYST |
| Generic Name | FETAL PULSE OXIMETER |
| Product Code | MMA |
| Date Received | 2002-02-14 |
| 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 | 365687 |
| 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. Life Threatening | 2002-02-14 |