BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50 VENTILATOR

    MDR report key: 1240584 · Received August 29, 2008

    Report

    Report Number
    2023050-2008-00061
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 1, 2008
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SYSTEM FAILURE OCCURRED WHILE PT WAS ON THE VENTILATOR RUNNING BY AC WALL CURRENT. PT WAS REMOVED FROM VENTILATOR AND MANUALLY VENTILATED FOR 20 MINUTES, AND THEN HE WAS PLACED ON BACK UP VENTILATOR. THE VENTILATOR ALARMED; HOWEVER, THERE WAS NOT ENOUGH TIME FOR THE USER/CAREGIVER TO TAKE APPROPRIATE ACTION. PLEASE NOTE THAT THERE WERE NO SERIOUS INJURIES IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR