BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50 VENTILATOR

    MDR report key: 1210988 · Received July 23, 2008

    Report

    Report Number
    2023050-2008-00055
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 24, 2008
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE UNIT ALARMED WITH UNK ERROR MESSAGE. THE UNIT THEN STOPPED WORKING. THE CAREGIVER PLACED THE PT ON THE BACKUP VENTILATOR. THE INCIDENT OCCURRED WHILE THE PT WAS IN HIS WHEELCHAIR. THE UNIT WAS RUNNING ON DC POWER. PLEASE NOTE THAT THERE WAS NO SERIOUS INJURY OR DEATH IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR