BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DDRCOMBI PLUS

    MDR report key: 3763396 · Received April 9, 2014

    Report

    Report Number
    9614430-2014-00002
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 9, 2014
    Manufacturer
    SWISSRAY MEDICAL AG
    Product Code
    MQB
    PMA / PMN Number
    K973710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE CONFORMING. THE INVESTIGATION OF THE DEVICE BY SWISSRAY AT THE CUSTOMER SITE RESULTED IN THE FOLLOWING FINDING: THE X-RAY SYSTEM WAS NOT CALIBRATED PROPERLY AFTER A SERVICE INTERVENTION AT THE CUSTOMER PERFORMED BY THE RESPONSIBLE TRAINED SERVICE TECHNICIAN. AFTER FINISHING THE INVESTIGATION, THE DEVICE WAS CALIBRATED 3 TIMES IN A ROW WITHOUT ANY ERROR. THE DEVICE WAS WORKING AS SPECIFIED AND ALL CALIBRATION FILES WERE AVAILABLE AS INTENDED. THERE WAS NO TECHNICAL FAILURE OF THE PRODUCT VERIFIABLE. THE ROOT CAUSE WAS IDENTIFIED AS HUMAN ERROR IN FAILING TO PERFORM THE CALIBRATION DUE TO UNKNOWN REASON. WITH THE CORRESPONDING CORRECTION SWISSRAY CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER WAS REPORTING THAT A PATIENT UNDERWENT AN UNNECESSARY SURGERY BECAUSE X-RAY IMAGES WERE INTERPRETED BY THE RADIOLOGIST AS A BROKEN IMPLANT (NAIL FIXATION FOR A FEMUR FRACTURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213050 DDRCOMBI PLUS MQB SWISSRAY MEDICAL AG

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization