BEUDAMED
    FDA Adverse Event Summary report: N

    HT50 VENTILATOR

    MDR report key: 1946068 · Received December 15, 2010

    Report

    Report Number
    3003135857-2010-00020
    Date Received
    December 15, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 19, 2010
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR GAVE AN AUDIBLE SHUTDOWN ALARM AND SUDDENLY STOPPED VENTILATING AT STAND BY MODE WHILE IN USE ON A PT. THE VENTILATOR WAS RUNNING ON INTERNAL BATTERY POWER AT THE TIME OF THIS INCIDENT. THE PT WAS AMBU BAGGED FOR 30 MINUTES UNTIL ALTERNATE VENTILATOR WAS ATTACHED. PLEASE NOTE THAT THERE WAS NO SERIOUS INJURY IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention