BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYDOROS LX-80

    MDR report key: 488241 · Received October 7, 2003

    Report

    Report Number
    2240869-2003-00019
    Event Type
    Malfunction
    Date Received
    October 7, 2003
    Date of Event
    August 14, 2003
    Report Date
    August 25, 2003
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IZO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CLAIMS POLYDOROS LX-80 X-RAY GENERATOR CAUGHT ON FIRE. THIS UNIT WAS PURCHASED BY THE CUSTOMER AND WAS NOT BEING SERVICED BY SIEMENS UNTIL AFTER THE EVENT. AFTER THE EVENT, SIEMENS WAS NOTIFIED AND BROUGHT THE UNIT BACK TO SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYDOROS LX-80 X-RAY GENERATOR IZO SIEMENS MEDICAL SOLUTIONS USA, INC. 5759001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other