BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU INC.

    MDR report key: 2450202 · Received February 7, 2012

    Report

    Report Number
    MW5024213
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 7, 2012
    Manufacturer
    AMBU, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT BEING BAGGED WITH AMBU BAG AND CHEST NOT RISING. WHITE PIECE ON THE EXHALATION SIDE BECAME UNSCREWED AND WAS LAYING ON PATIENT'S BED. NO HARM TO PATIENT, AS HE WAS PLACED ON VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU INC. NEONATAL RESPIRATORY CARE AMBU SPUR BTM AMBU, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Other