NELLCOR/PEDICAP *

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW1041936
MDR Report Key819221
Date Received2007-02-08
Date of Report2007-02-08
Date of Event2007-01-20
Date Added to Maude2007-02-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNELLCOR/PEDICAP
Generic NamePEDIATRIC CO2 DETECTOR
Product CodeCCC
Date Received2007-02-08
Model Number*
Catalog Number*
Lot Number6286086
ID Number*
Device Expiration Date2009-07-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key806710
ManufacturerTYCO HEALTHCARE GROUP/NELLCOR PURITAN BENNETT
Manufacturer Address* PLEASANTON CA * US


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2007-02-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.