BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50-H1

    MDR report key: 1061844 · Received May 12, 2008

    Report

    Report Number
    2023050-2008-00034
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    November 1, 2007
    Report Date
    April 17, 2008
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AS REPORTED, DURING USE, THE VENT HAD A DISTORTED ALARM SOUND AND WAS SENT TO SERVICING. UPON INSPECTION A TOTAL AUDIBLE ALARM FAILURE WAS FOUND. THE VENT WAS OPENED AND SIGNS OF CORROSION WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT50-H1 VENTILATOR CBK FLIGHT MEDICAL HT50-H1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN