BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESUSCITATOR

    MDR report key: 4964741 · Received August 4, 2015

    Report

    Report Number
    1417592-2015-00066
    Event Type
    Death
    Date Received
    August 4, 2015
    Report Date
    August 4, 2015
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    NHK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ADMINISTRATION OF CPR TO A RESIDENT WHO WAS IN CARDIAC ARREST, THE SWIVEL CONNECTOR BETWEEN THE MOUTHPIECE AND THE BAG BROKE. THE RESIDENT SUBSEQUENTLY DIED. THE VICE PRESIDENT OF CLINICAL SERVICES STATED THAT SHE COULD NOT CONFIRM THAT THE ISSUE WITH THE AMBU BAG CAUSED OR CONTRIBUTED TO THE RESIDENT'S OUTCOME. NO SAMPLE WAS RETURNED FOR EVALUATION. NO LOT NUMBER WAS PROVIDED. THE ROOT CAUSE FOR THE REPORTED BREAK OF THE SWIVEL CONNECTOR IS NOT KNOWN. THE OVERALL CONDITION OF THE AMBU BAG PRIOR TO USE IS ALSO NOT KNOWN.

    Description of Event or Problem · 1

    DURING ADMINISTRATION OF CPR TO A RESIDENT WHO WAS IN CARDIAC ARREST, THE SWIVEL CONNECTOR BETWEEN THE MOUTHPIECE AND THE BAG BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507697 RESUSCITATOR NHK MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O