BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL DIAGNOST

    MDR report key: 1942858 · Received December 21, 2010

    Report

    Report Number
    3003768251-2010-00071
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 30, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL CURRENTLY ONGOING AND CONCLUSIONS WILL BE SENT IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ABOUT ONE EVENT OF A DATA LOSS WHERE 20 IMAGES WERE LOST WITHOUT ANY WARNING. THE CUSTOMER HAD TO CALL BACK THE PATIENTS AND REWORK ON PATIENT WITH SECOND TIME EXPOSURE. THIS WAS REPORTED AS ONE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL DIAGNOST MQB PHILIPS MEDICAL SYSTEMS 712020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1