BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50 VENTILATOR

    MDR report key: 1240484 · Received August 29, 2008

    Report

    Report Number
    2023050-2008-00062
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    July 6, 2008
    Report Date
    August 2, 2008
    Manufacturer
    FLIGHT MEDICAL LTD.
    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

    REPORTEDLY, THE PT'S FAMILY NOTICED THAT; WHILE CONNECTED TO A/C POWER; HT50 VENTILATOR WAS ON INTERNAL BATTERY AND WOULD NOT CHARGE OR SHOW GREEN A/C POWER LIGHT. THEY DID NOT KNOW HOW LONG THIS CONDITION HAD LASTED. THERE WAS NO ALARM OR WARNING THAT THE VENTILATOR WOULD NOT TAKE A/C POWER. THE VENTILATOR REPORTEDLY STOPPED WORKING, AND SHUT DOWN COLD WITH A SIMULTANEOUS ALARM, HOWEVER, THE ALARM DID NOT PROVIDE A WARNING PRIOR TO THE EVENT. AFTER THIS INCIDENT, THE VENTILATOR WILL NOT TURN ON WHILE PLUGGED INTO A/C POWER. IT GOES TO AN ALL RED LIGHT ALARM (AUDIO) ALERT AND FREEZES THERE NON-RESPONSIVE TO ACTUATION OF CONTROLS. ALARM/LIGHTS CONTINUE UNTIL UNPLUGGED FROM A/C POWER AND THE INTERNAL POWER RUNS DOWN. THE CAREGIVER BAGGED THE PT FOR APPROX 2 HOURS BECAUSE THEY HAD NOT BROUGHT A BACK UP VENTILATOR. PLEASE NOTE THAT THERE WERE NO PERMANENT PT INJURIES IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR