BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 2941255 · Received January 17, 2013

    Report

    Report Number
    2023050-2013-00034
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 5, 2012
    Report Date
    January 6, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, IT WAS FOUND THAT THE VENTILATOR SCREEN FROZE AND THE TOUCH PANEL WAS NON FUNCTIONAL. UPON FURTHER EVALUATION BY THE DISTRIBUTOR, THE CONTROL BOARD WAS FOUND TO BE DEFECTIVE. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27106 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1