BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50-H1 VENTILATOR

    MDR report key: 3223522 · Received July 10, 2013

    Report

    Report Number
    3003135857-2013-00001
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 25, 2013
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, DURING PT USE, THE VENTILATOR STOPPED VENTILATING AND SHUT DOWN WITHOUT AN ALARM. THE PT WAS MANUALLY VENTILATED BEFORE TRANSFERRING TO ANOTHER UNIT. THERE WERE NO REPORTED SERIOUS OR NEGATIVE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316145 HT50-H1 VENTILATOR CBK, NOU CBK FLIGHT MEDICAL HT50-H1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention