BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESUSCITATOR WITH MASK LF-NEO INFANT AMBU BAG

    MDR report key: 16138241 · Received January 10, 2023

    Report

    Report Number
    MW5114271
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    January 4, 2023
    Report Date
    January 9, 2023
    Manufacturer
    AMBU INC. / AMBU LIMITED
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFANT AMBU BAGS FOUND IN STOCK WITH SMALL CRACK WHERE MENOMETER HOOKS ONTO BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900077 RESUSCITATOR WITH MASK LF-NEO INFANT AMBU BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM AMBU INC. / AMBU LIMITED 1000608236
    900078 RESUSCITATOR WITH MASK LF-NEO INFANT AMBU BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM AMBU INC. / AMBU LIMITED 1000624379
    900079 RESUSCITATOR WITH MASK LF-NEO INFANT AMBU BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM AMBU INC. / AMBU LIMITED 1000605041
    900080 RESUSCITATOR WITH MASK LF-NEO INFANT AMBU BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM AMBU INC. / AMBU LIMITED 1000608236

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown