NELLCOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-04 for NELLCOR manufactured by Tyco Healthcare Group Lf - Nellcor Puritan Bennett Div..

Event Text Entries

[3534937] Pedi-caps didn't turn color when trying to identify if pt still intubated. Third one used on pt did not turn color indicating pt was still intubated when endotracheal tube still in exact same position.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5030442
MDR Report Key3151774
Date Received2013-06-04
Date of Report2013-05-24
Date of Event2013-02-14
Date Added to Maude2013-06-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNELLCOR
Generic NamePEDI-CAP CO2 DETECTOR, #1
Product CodeCCL
Date Received2013-06-04
Lot Number0238052
ID Number(01)00840029001493
Device Expiration Date2013-08-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerTYCO HEALTHCARE GROUP LF - NELLCOR PURITAN BENNETT DIV.
Manufacturer AddressPLEASANTON CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2013-06-04

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