MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-22 for PULSE OXIMETER UNK NA manufactured by Nellcor.
[20921503]
Measures fetal oxygenation in labor. Device gave normal readings. However, the baby died during labor. Autopsy consistent with hypoxia. Chronic hypoxia is cause of death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025617 |
| MDR Report Key | 405632 |
| Date Received | 2002-07-22 |
| Date of Report | 2002-07-22 |
| Date of Event | 2002-06-03 |
| Date Added to Maude | 2002-07-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PULSE OXIMETER |
| Generic Name | FETAL PULSE OXIMETER |
| Product Code | MMA |
| Date Received | 2002-07-22 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 394623 |
| Manufacturer | NELLCOR |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2002-07-22 |