BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3040530 · Received April 3, 2013

    Report

    Report Number
    2023050-2013-00272
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 19, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, "BACKUP BATTERY FAILS, CALL SVC" ERROR MESSAGE OCCURRED. THE EXTERNAL BATTERY SHOWED A CHARGE OF 88% AND THE INTERNAL BATTERY SHOWED A CHARGE OF 84%. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136087 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1