BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T70 PLUS VENTILATOR

    MDR report key: 2960585 · Received January 25, 2013

    Report

    Report Number
    2023050-2013-00066
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Report Date
    December 7, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, WHEN THE AC POWER WAS DISCONNECTED FROM THE VENTILATOR, IT FAILED TO RECOGNIZE THE EXTERNAL POWER PAC BATTERY. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35334 T70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1