BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU KING MASK/DISPOSABLE ANESTHESIA FACE MASK

    MDR report key: 8343158 · Received February 14, 2019

    Report

    Report Number
    MW5084075
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    February 6, 2019
    Report Date
    February 13, 2019
    Manufacturer
    AMBU A/S
    Product Code
    BSJ
    UDI-DI
    00612649184777
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING RESUSCITATION CPAP MASK WENT COMPLETELY FLAT, MAKING IT EXTREMELY DIFFICULT TO MAINTAIN A SEAL FOR INFANT. PRIOR TO DELIVERY, MASK WAS CHECKED BY 3 NURSES INCLUDING THIS RN AND THE NICU RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134792 AMBU KING MASK/DISPOSABLE ANESTHESIA FACE MASK MASK, GAS, AHESTHETIC BSJ AMBU A/S 1000181222 00612649184777

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Life Threatening