MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2002-04-11 for OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM N400 NA manufactured by Nellcor Puritan Bennett.
[263560]
March 2002 nellcor puritan bennett received information stating that the oxifirst oxygen saturation monitoring system was providing reassuring "fspo2" with non-reassuring heart rate. No intervention performed, doctor continued with normal delivery after which patient required "some resuscitation", patient was transferred to the transitional care nursery. Current condition of the patient is unknown. Device serial number is unknown and the sensor was discarded. Facility has been contacted and no other information about the reported event is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025525-2002-00004 |
| MDR Report Key | 387759 |
| Report Source | 06,07 |
| Date Received | 2002-04-11 |
| Date of Report | 2002-03-11 |
| Date of Event | 2001-09-08 |
| Date Mfgr Received | 2002-03-11 |
| Date Added to Maude | 2002-04-15 |
| 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 AVENUE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7606035800 |
| 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 MONITORING SYSTEM |
| Generic Name | FETAL PULSE OXIMETER |
| Product Code | MMA |
| Date Received | 2002-04-11 |
| Model Number | N400 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 376787 |
| 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 | 2002-04-11 |