BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3040120 · Received April 3, 2013

    Report

    Report Number
    2023050-2013-00275
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 18, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PATIENT USE, THE GASKET ON THE INTAKE GAS PORT CONNECTION FELL OFF. UPON REPLACING THE GASKET, THIS ISSUE WAS RESOLVED. THE PATIENT WAS REPORTED TO HAVE SATURATED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136297 HT70 VENTILATOR NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1