BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 2894455 · Received December 27, 2012

    Report

    Report Number
    2023050-2012-00375
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 14, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TESTING, THE SCREEN WAS LOCKED UP AND NOT ACCEPTING TOUCH COMMANDS. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1