BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 3181684 · Received June 14, 2013

    Report

    Report Number
    2023050-2013-00433
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, THE TOUCH SCREEN FROZE AND IT COULD NOT BE CALIBRATED. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271193 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS HT70PM

    Patients

    Seq Age Sex Outcome Treatment
    1