BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU BAG

    MDR report key: 3874144 · Received June 10, 2014

    Report

    Report Number
    MW5036592
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 7, 2014
    Report Date
    June 6, 2014
    Manufacturer
    VENTILAB
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EXTRA PRESSURE WAS REQUIRED WHILE ATTEMPTING TO ADMINISTER MED VIA AMBU BAG; DEFORMED BAG WAS NOTED. NO PATIENT HARM. REPLACED WITH NEW BAG. TREATMENT CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338281 AMBU BAG BTM VENTILAB AF-1000 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR