BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA1000

    MDR report key: 1925526 · Received November 8, 2010

    Report

    Report Number
    3004526608-2010-00032
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K043415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THAT THE SIEMENS IMAGE HAD MISSING PIXEL SPACING IN HEADER AND THE SIEMENS MODALITY WAS SENDING DATA IN A MANNER INCONSISTENT WITH OTHER MAMMOGRAPHY SCANNERS. IN ADDITION, ESTIMATED RADIOGRAPHIC MAGNIFICATION FACTOR IS NOT BEING USED IN THE HEADER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES CREATED ON SIEMENS MAMMOGRAPHIC SYSTEM WERE SENT TO THE REPORTED DEVICE. THE SHOWN VALUES IN RA1000 ARE INCORRECT. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RA1000 LLZ GE HEALTHCARE UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1