BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50 VENTILATOR

    MDR report key: 2243362 · Received August 23, 2011

    Report

    Report Number
    3003135857-2011-00019
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 29, 2011
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE PT'S MOTHER NOTICED A TICKING/CLICKING SOUND FROM THE VENTILATOR WHEN THE PT WAS TRANSFERRED FROM THE WHEEL CHAIR TO THE BED AT HOME. IT WAS ALSO REPORTED THAT THE PT FELT SHE WAS NOT GETTING ENOUGH AIR. THE VENTILATOR WAS SHOOTING OUT PUFFS OF AIR BUT NOT VENTILATING. THE PT WAS AMBU BAGGED AND THEN SWITCHED TO A BACK-UP VENTILATOR. PLEASE NOTE THAT THERE WAS NO PERMANENT 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 Required Intervention