BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 3102610 · Received May 1, 2013

    Report

    Report Number
    2023050-2013-00354
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 9, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, THE TOUCH SCREEN DID NOT WORK AND VENTILATION COULD NOT BE STARTED. THE DISTRIBUTOR REPLACED THE SINGLE BOARD COMPUTER AND THE TOUCH SCREEN AND THE VENTILATOR WORKED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190673 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70PM

    Patients

    Seq Age Sex Outcome Treatment
    1