BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50 VENTILATOR

    MDR report key: 1942104 · Received December 17, 2010

    Report

    Report Number
    3003135857-2010-00022
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 18, 2010
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, WHEN A PT WAS BEING TRANSFERRED THE VENTILATOR STOPPED VENTILATING WITH LED SYSTEM FAILURE ALARM. A CAREGIVER PRESSED ON/STANDBY BUTTON AND THE VENTILATOR STARTED WORKING AGAIN. THE VENTILATOR WAS RUNNING ON INTERNAL BATTERY POWER AT THE TIME OF THIS INCIDENT. IT IS UNK IF THERE WAS AN AUDIBLE ALARM SINCE THE USER HAD SET THE ALARM ON MUTE ON PURPOSE. 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 HT50-H1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK