BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMORAY COMPACT EOS

    MDR report key: 969479 · Received December 21, 2007

    Report

    Report Number
    1063474-2007-00002
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Date of Event
    December 7, 2007
    Report Date
    December 21, 2007
    Manufacturer
    AGFA HEALTHCARE GMBH
    Product Code
    EGY
    PMA / PMN Number
    K981280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. ROOT CAUSE FOR THE FIRE HAS NOT BEEN DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    A MAMORAY COMPACT E.O.S. CAUGHT FIRE AND WAS BADLY DAMAGED, FORCING EVACUATION OF THE CLINIC. NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMORAY COMPACT EOS AUTOMATIC RADIOGRAPHIC FILM PROCESSOR EGY AGFA HEALTHCARE GMBH MAMORAYCOMPACTEOS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR