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.
[17888112]
Male who was born via emergency cs with apgars 3/7. The infant had one initial cry and then was apneic and was intubated. Five days later - infant had an airway obstruction below the level of the et and required reintubation. The nellcor co2 detector was applied and a delay of greater than 1-2 minutes occurred before a color change was noted. This delay resulted in another reintubation for the infant.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1041936 |
MDR Report Key | 819221 |
Date Received | 2007-02-08 |
Date of Report | 2007-02-08 |
Date of Event | 2007-01-20 |
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 | 806710 |
Manufacturer | TYCO HEALTHCARE GROUP/NELLCOR PURITAN BENNETT |
Manufacturer Address | * PLEASANTON CA * US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Deathisabilit | 2007-02-08 |