BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50-H

    MDR report key: 1122383 · Received June 11, 2008

    Report

    Report Number
    2023050-2008-00042
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 16, 2008
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY A RESPIRATORY THERAPIST, THE UNIT COMPLETELY SHUT DOWN ITS POWER DURING USE ON A PT WITH NO AUDIBLE ALARM. THE RESPIRATORY THERAPIST APPLIED A MANUAL BREATH APPARATUS TO THE PT. PLEASE NOTE THERE WAS NO DEATH OR SERIOUS INJURY IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN