BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3223826 · Received July 10, 2013

    Report

    Report Number
    2023050-2013-00477
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 20, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, DURING PATIENT USE, "PINT FAILURE" AND "MOTOR SLOW" ALARMS OCCURRED. THE VENTILATOR STOPPED VENTILATING. THE PATIENT WAS MANUALLY VENTILATED AND SWITCHED TO ANOTHER UNIT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316204 HT70 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention