BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3012546 · Received March 15, 2013

    Report

    Report Number
    2023050-2013-00184
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 19, 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, ADD'L PATIENT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING PATIENT USE, WHEN THE AC CABLE WAS CONNECTED, SUDDENLY "NO EXTERNAL POWER" AND "MOTOR FAULT" ALARMS OCCURRED. AT THE TIME, THE PATIENT WAS CONSCIOUS AND HE SAID "THE OUTPUT GAS IS LOW". THEN THE PATIENT 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
    110845 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention