BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3192910 · Received June 25, 2013

    Report

    Report Number
    2023050-2013-00452
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 11, 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, A "SYSTEM ERROR" AND EXCEPTION DEVICE ALERT" OCCURRED AND THE PATIENT'S SPO2 LEVEL DROPPED FROM 100% TO 70%. THE PATIENT WAS MANUALLY VENTILATED AND TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO FURTHER PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288173 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention