BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 3102568 · Received May 1, 2013

    Report

    Report Number
    2023050-2013-00369
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    May 15, 2013
    Report Date
    April 15, 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 UNIT SHUT DOWN AND REBOOTED. THIS EXPERIENCE WAS RECURRED AGAIN AND DID NOT GET RECORDED IN THE EVENT HISTORY LOG. THERE WAS NO PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190562 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70PM

    Patients

    Seq Age Sex Outcome Treatment
    1