BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYDIAGNOST DIGITAL

    MDR report key: 2243858 · Received August 24, 2011

    Report

    Report Number
    3003768251-2011-00056
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    July 25, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    IXR
    PMA / PMN Number
    K970640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) TROUBLESHOOT THE SYSTEM AND FOUND A PROBLEM WITH METAL BAND UNDER THE SCOPO UNIT. THE METAL BAND IS VERY THIN WITHOUT SHARP EDGES. THE FSE REPLACED THE METAL BAND, THIS SOLVED THE PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE METAL STRIP FELL OUT DURING A FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYDIAGNOST DIGITAL IXR PHILIPS MEDICAL SYSTEMS DMC GMBH 706031

    Patients

    Seq Age Sex Outcome Treatment
    1