BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3896792 · Received May 19, 2014

    Report

    Report Number
    2023050-2014-00205
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADD'L INFO AVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT AN HT70 VENTILATOR STARTED ALARMING WITHOUT BEING IN USE. THE CUSTOMER ATTEMPTED TO SILENCE THE DEVICE BY PRESSING THE SILENCE/RESET BUTTON BUT IT DID NOT WORK. A BIOMEDICAL TECHNICIAN THEN CONNECTED THE UNIT TO AC POWER BUT STILL COULD NOT SILENCE THE DEVICE. THE TECHNICIAN TRIED TO TURN ON THE UNIT BY PRESSING THE POWER ON SWITCH BUT THE DEVICE FAILED TO POWER ON. THE TECHNICIAN HAD TO OPEN THE UNIT TO DISCONNECT THE CABLE SPEAKER TO SILENCE THE ALARM. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297836 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1