BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUMONE CARDIAC

    MDR report key: 785905 · Received November 10, 2006

    Report

    Report Number
    1318879-2006-00002
    Event Type
    Malfunction
    Date Received
    November 10, 2006
    Date of Event
    October 31, 2006
    Report Date
    November 10, 2006
    Manufacturer
    INFIMED, INC.
    Product Code
    JAA
    PMA / PMN Number
    012490
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TIMING ISSUE BETWEEN THE GENERATION INTERFACE MODULE IN THE DIGITAL X-RAY SYSTEM AND THE GE ADVANTX GENERATOR. THE OPERATING SYSTEM WAS RE-CONFIGURED AND THE SYSTEM IS NOW OPERATING NORMALLY.

    Description of Event or Problem · 1

    DURING AN ANGIOPLASTY PROCEDURE PRIOR TO SURGERY, DIGITAL X-RAY SYSTEM LOCKED UP AND PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUMONE CARDIAC IMAGE-INTENSIFIED FLOURO X-RAY SYSTEM JAA INFIMED, INC. P1 CARDIAC *

    Patients

    Seq Age Sex Outcome Treatment
    1 *