BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILLATOR

    MDR report key: 2894446 · Received December 27, 2012

    Report

    Report Number
    2023050-2012-00369
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 13, 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

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, NO PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, A "SWITCHED TO BACKUP BATTERY" OCCURRED WHEN THE AC CABLE WAS CONNECTED. REPLACING THE BATTERY RESOLVED THE ISSUE. NO SERIOUS INJURY WAS REPORTED IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1