BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 2823805 · Received October 29, 2012

    Report

    Report Number
    2023050-2012-00237
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 3, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, PT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PT USE, THE VENTILATOR SHUT DOWN AND COULD NOT BE POWERED UP. THE UNIT'S DISPLAY WENT DARK BUT THE AUDIBLE ALARMS REMAINED ON. THE PT WAS MANUALLY TRANSFERRED WHILE BEING TRANSFERRED TO ANOTHER VENTILATOR. THERE WERE NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention