BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 2922346 · Received January 11, 2013

    Report

    Report Number
    2023050-2013-00033
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 7, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, NO PT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, WHEN THE VENTILATOR WAS CONNECTED TO THE AC CABLE, "NO EXTERNAL POWER" AND "SWITCHED TO BACKUP BATTERY" ALARMS OCCURRED. AT THAT TIME, THE AC INDICATOR WAS NOT LIT, THE PT WAS AMBU BAGGED AND SWITCHED TO ANOTHER VENTILATOR. NO PERMANENT INJURY WAS REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18012 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention