BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIGITAL DIAGNOST

    MDR report key: 2222858 · Received August 10, 2011

    Report

    Report Number
    3003768251-2011-00044
    Event Type
    Other
    Date Received
    August 10, 2011
    Report Date
    January 18, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER INVESTIGATION IDENTIFIED THAT THE PHYSICIAN WAS NOT USING THE SYSTEM CORRECTLY; THE AUTOMATIC STITCHING PROCESS CAN LEAD TO AN INCORRECT IMAGE DUE TO PT MOVEMENTS, PT BREATHING AND RULER MOVEMENT. 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 REPORTED ABOUT A STITCHING PROBLEM, WHICH CAN POSSIBLE LEAD TO A MISDIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL DIAGNOST MQB PHILIPS MEDICAL SYSTEMS DMC GMBH 712052

    Patients

    Seq Age Sex Outcome Treatment
    1