BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3112014 · Received May 7, 2013

    Report

    Report Number
    2023050-2013-00377
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, DURING PATIENT USE, THE VENTILATOR AUTOCYCLED AND HAD TO BE REMOVED FROM THE PATIENT. THE PATIENT WAS MANUALLY VENTILATED AND PLACED BACK ON THE SAME VENTILATOR AFTER ADJUSTMENTS WERE MADE; HOWEVER, THERE WAS STILL AN OCCASIONAL AUTO CYCLING. THERE WERE NO FURTHER ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197776 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR