BEUDAMED
    FDA Adverse Event Summary report: N

    DIGITALDIAGNOST

    MDR report key: 2222787 · Received August 9, 2011

    Report

    Report Number
    3003768251-2011-00045
    Date Received
    August 9, 2011
    Report Date
    April 1, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC ENGINEER INVESTIGATION IDENTIFIED THAT THE PHYSICIAN WAS NOT USING THE SYSTEM CORRECTLY, ANALYSES OF THE IMAGES USED ON THIS SITE SHOWS THAT THE RULER IS PARTLY OUTSIDE THE COLLIMATION AND WAS TILTED WITH RESPECT TO THE DETECTOR. THE RESULT OF THAT IS THAT THE RULER CANNOT BE DETECTED RELIABLY AND THE HORIZONTAL COMPENSATION FOR PT MOVEMENT CAN BE AFFECTED NEGATIVELY. AS PART OF THE AUTOMATED STITCHING WORKFLOW, IT IS IMPORTANT THAT THE PHYSICIAN REVIEWS THE INDIVIDUAL IMAGES AGAINST THE COMPOSITE IMAGE. THE PHYSICIAN HAS BEEN RETRAINED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED "THERE IS A STITCHING PROBLEM." HE REPORTED THAT THERE IS SOMETHING WRONG WITH AUTO STITCHING/ASSEMBLING OF IMAGES. THE FIRST STITCHING COMPOSITE IMAGE, THE LEG SHOWS THAT IT SEEMS TO BE BROKEN THEN AFTER A FEW HOURS, A SECOND X-RAY IS TAKEN AND IT LOOKS LIKE IT IS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITALDIAGNOST MQB PHILIPS MEDICAL SYSTEMS DMC GMBH 712020

    Patients

    Seq Age Sex Outcome Treatment
    1