BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 2860543 · Received December 4, 2012

    Report

    Report Number
    2023050-2012-00335
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 20, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, A "BACKUP BATTERY LOW" ALARM OCCURRED WHEN THE AC CABLE WAS REMOVED. WHEN THE HOSPITAL STAFF REMOVED THE POWER PAC BATTERY, THE HT70 VENTILATOR SHUT DOWN WITH A "SHUTDOWN IMMINENT" ALARM. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1