BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50-H VENTILATOR

    MDR report key: 3001368 · Received March 11, 2013

    Report

    Report Number
    2023050-2013-00167
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, PT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, A 'LOW PRESSURE' ALARM OCCURRED. THE VENTILATOR STOPPED VENTILATING AND ALL KEY OPERATIONS WERE NON-FUNCTIONAL. THE NURSE WAS UNABLE TO POWER OFF THE VENTILATOR. THE PT WAS AMBU BAGGED AND SWITCHED TO ANOTHER VENTILATOR. NO PERMANENT PT INJURY WAS REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101552 HT50-H VENTILATOR CBK, NOU CBK FLIGHT MEDICAL HT50-H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention