BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    AVIEW 2 ADVANCE

    MDR report key: 16389373 · Received February 16, 2023

    Report

    Report Number
    1220828-2023-00004
    Event Type
    No answer provided
    Date Received
    February 16, 2023
    Report Date
    February 17, 2023
    Manufacturer
    AMBU A/S
    Product Code
    FEM
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MONITOR WAS NOT RECEIVED FOR INVESTIGATION SINCE IT WAS DISPOSED OF BY FIRE BRIGADE. PICTURES WERE PROVIDED. INVESTIGATION IS STILL ONGOING. THE EVENT IS SUSPECTED TO BE CAUSED BY THE IMPACT ON THE BATTERY WHEN THE MONITOR WAS DROPPED ONTO THE FLOOR.

    Description of Event or Problem · 0

    THE AVIEW 2 ADVANCE DISPLAY UNIT WAS DROPPED FROM APPROXIMATELY 1.5 METERS. SPARKS WAS OBSERVED AND THE MONITOR CAUGHT FIRE. THE DISPLAY LEFT A BURN MARK ON THE FLOOR. FIRE BRIGADE WAS CALLED TO HANDLE THE MONITOR AND DISPOSED IT. PATIENT WAS NOT INVOLVED. NO HARM TO USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358369 AVIEW 2 ADVANCE AVIEW 2 ADVANCE FEM AMBU A/S 405011000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other