BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE ADULT MANUAL RESUSCITATOR

    MDR report key: 2103374 · Received May 20, 2011

    Report

    Report Number
    MW5020699
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AIRLIFE "AMBU" TYPE BAG/MASK USED FOR EMERGENCY INTUBATION. ELBOW CONNECTOR BETWEEN BAG AND MASK SEPARATED AT SWIVEL JOINT LEAVING AN APPROX 13 MM CONNECTOR UNSUITABLE FOR CONNECTION TO ENDOTRACHEAL TUBE. PT SUFFERED HYPOXIC PERIOD WHILE A SECOND BAG WAS LOCATED - IT FAILED THE SAME WAY. VENTILATION WAS ACCOMPLISHED WITH MOUTH-TO-TUBE UNTIL CONNECTOR COULD BE REASSEMBLED. FINAL PT OUTCOME STILL UNK. ATTEMPTED TO CONTACT MFR BUT UNABLE AFTER-HOURS. DOZENS OF SIMILAR INCIDENTS REPORTED IN THE PAST WEEK IN OUR INSTITUTION. REASON FOR USE: RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE ADULT MANUAL RESUSCITATOR BAG/MASK BTM CARDINAL HEALTH 4251A Y10K6999

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening