BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 2941326 · Received January 31, 2013

    Report

    Report Number
    2023050-2013-00074
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    November 16, 2012
    Report Date
    January 16, 2013
    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, THE OXYGEN PERCENTAGES WERE OBSERVED TO BE DRIFTING. CALIBRATION OF THE OXYGEN SENSOR DID NOT SOLVE THIS ISSUE. HOWEVER, REPLACING THE SENSOR RESOLVED IT. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42711 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70PM

    Patients

    Seq Age Sex Outcome Treatment
    1