BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 3001964 · Received March 11, 2013

    Report

    Report Number
    2023050-2013-00172
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 19, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING STAFF TRAINING, A TOUCH SCREEN FAILURE OCCURRED. THE USER WAS UNABLE TO CHANGE SETTINGS DUE TO UNRESPONSIVE SCREEN. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101393 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70PM

    Patients

    Seq Age Sex Outcome Treatment
    1