BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50 VENTILATOR

    MDR report key: 2243500 · Received August 17, 2011

    Report

    Report Number
    3003135857-2011-00016
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    FLIGHT MEDICAL, LTD.
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, WHILE THE HT50 VENTILATOR WAS BEING SERVICED AND TESTED USING A NURSE CALL CABLE, THE CABLE WAS MANUALLY MOVED AND THE VENTILATOR ALARMED AND THEN SHUT DOWN UNEXPECTEDLY. THERE WAS NO PT INVOLVEMENT WITH THIS CASE. THE MFR OF THIS VENTILATOR AND CABLE, FLIGHT MEDICAL, HAS NOTIFIED NEWPORT MEDICAL THAT THEY ARE CONDUCTING A RECALL FOR THIS CABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA