BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 8000CA

    MDR report key: 1521780 · Received October 27, 2009

    Report

    Report Number
    2183646-2009-00005
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Date of Event
    October 15, 2009
    Report Date
    October 26, 2009
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    MUD
    PMA / PMN Number
    K090807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF SINGLE-USE DISPOSABLE 8000CA SENSOR HAS A POWER TO GROUND SHORT, THE DC/DC ISOLATOR COMPONENT IN THE 7600B REUSABLE POD MAY OVERHEAT.

    Description of Event or Problem · 1

    A MODEL, 7600B REV A, STOPPED WORKING DURING USE AND EXHIBITED A VISIBLE DEFORMATION ON THE ENCLOSURE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 8000CA CEREBRAL SENSOR MUD NONIN MEDICAL, INC. 8000CA 8000CA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR