MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-08 for NELLCOR/PEDICAP * manufactured by Tyco Healthcare Group/nellcor Puritan Bennett.
[591392]
A 24 weeks gestation infant male was born via emergency cs. The infant had one initial cry when was apenic. He was intubated without difficulty - nellcor co2 detector was applied and a delay of greater than 1 minute occurred before a color change was noted. The delay resulted in reintubation for the infant. Apagar 1/8.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041937 |
| MDR Report Key | 819231 |
| Date Received | 2007-02-08 |
| Date of Report | 2007-02-08 |
| Date of Event | 2007-01-15 |
| Date Added to Maude | 2007-02-22 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NELLCOR/PEDICAP |
| Generic Name | PEDIATRIC CO2 DETECTOR |
| Product Code | CCC |
| Date Received | 2007-02-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 6286086 |
| ID Number | * |
| Device Expiration Date | 2009-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 806720 |
| Manufacturer | TYCO HEALTHCARE GROUP/NELLCOR PURITAN BENNETT |
| Manufacturer Address | * PLEASANTON CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-02-08 |