BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3060898 · Received April 10, 2013

    Report

    Report Number
    2023050-2013-00308
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 22, 2013
    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

    DURING TESTING, A "BACKUP BATTERY LOW" ALARM OCCURRED WHEN THE POWER PAC BATTERY WAS REMOVED. SOON AFTER, REPORTEDLY, THE VENTILATOR SHUTDOWN. REPLACING THE INTERNAL BATTERY RESOLVED THE ISSUE. THERE WAS NO PT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153561 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1