BEUDAMED
    FDA Adverse Event Death Summary report: N

    GM85

    MDR report key: 17244413 · Received July 2, 2023

    Report

    Report Number
    3004938766-2023-00013
    Event Type
    Death
    Date Received
    July 2, 2023
    Date of Event
    May 15, 2023
    Report Date
    June 30, 2023
    Manufacturer
    SAMSUNG ELECTRONICS CO., LTD.
    Product Code
    IZL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INCIDENT OCCURRED ON (B)(6) 2023, AND NEUROLOGICA WAS INFORMED ON JUNE 7, 2023. NEUROLOGICA IMMEDIATLEY DISPATCHED FIELD SERVICE ENGINEERS TO THE SITE TO ASSESS THE SYSTEM. AFTER CONVERSATIONS WITH STAFF MEMBERS AND ASSESSMENT OF THE DEVICE, IT WAS DETERMINED THAT THE IMAGE ROTATION WAS COMPLETED BY THE CUSTOMER. THE SYSTEM WAS THOROUGHLY REVIEWED AND NO ISSUES WERE FOUND WITH THE SYSTEM. ANY ADDITIONAL INFORMATION WILL BE FILED UNDER A FOLLOW-UP MDR.

    Description of Event or Problem · 0

    CUSTOMER CALLED AND INFORMED CALL CENTER THAT WHILE USING THE DEVICE, THE IMAGE USED TO PERFORM A SURGERY WAS ROTATED. THE SURGEON OPERATED ON THE PATIENT WITH MISINFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253542 GM85 COMMON DEVICE NAME DIGITIAL DIAGNOSTIC X-RAY SYSTEM IZL SAMSUNG ELECTRONICS CO., LTD. DGR2ABA1BDNNYW

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death