2K8027

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-10 for 2K8027 manufactured by Carefusion.

Event Text Entries

[4202367] The pt's mapleson bag came apart. The tape holding the green bag to connector came undone. Pt changed to hand ventilation with ambu bag. No decompensation with event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5034411
MDR Report Key3628057
Date Received2014-02-10
Date of Report2014-02-07
Date of Event2013-11-29
Date Added to Maude2014-02-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Generic NameMAPLESON BAG
Product CodeKNE
Date Received2014-02-10
Model Number2K8027
Lot Number0000609407
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION
Manufacturer AddressVERNON HILLS IL 60061 US 60061


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-02-10

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