BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50 VENTILATOR

    MDR report key: 2243363 · Received August 18, 2011

    Report

    Report Number
    3003135857-2011-00017
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR STOPPED VENTILATING WHILE IN USE ON A PT. THE PT WAS TRANSFERRED TO THE HOSPITAL AND WAS SWITCHED TO ANOTHER VENTILATOR. PLEASE NOTE THAT THERE WAS NO PERMANENT INJURY REPORTED 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 50 YR Required Intervention