BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST

    MDR report key: 1994298 · Received January 14, 2011

    Report

    Report Number
    3003768251-2011-00004
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    December 17, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING AND CONCLUSIONS WILL BE SENT IN A FOLLOW UP REPORT BY (B)(4) 2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ISITE PACS SHOWS IMAGE ARTIFACTS WHICH WERE NOT VISIBLE ON THE MONITOR.

    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