BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY RF180

    MDR report key: 17445611 · Received August 2, 2023

    Report

    Report Number
    3002807092-2023-00001
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 31, 2023
    Manufacturer
    GENERAL MEDICAL MERATE S.P.A.
    Product Code
    JAA
    PMA / PMN Number
    K173395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    GE HEALTHCARE INSTALLER RECEIVED AN ELECTRIC SHOCK WHILE INSTALLING THE X-RAY GENERATOR (MODEL: INDICO IQ, CPI S/N (B)(6)) MANUFACTURED BY COMMUNICATIONS & POWER INDUSTRIES (CPI). THE INDICO IQ GENERATOR IS A MEDICAL DEVICE ALREADY REGISTERED IN THE UNITED STATES (REGISTERED ESTABLISHMENT NUMBER: 3002975048). THIS GENERATOR IS A COMPONENT OF THE DISCOVERY RF180 SYSTEM MANUFACTURED BY GMM (510(K) NUMBER: K173395). THE SHOCK OCCURRED WHEN THE INSTALLER ACCIDENTALLY TRIPPED WHILE WALKING TOWARD THE X-RAY GENERATOR THAT WAS ON AND BEING CALIBRATED, AND THE GENERATOR COVERS HAD BEEN REMOVED (AN UNUSUAL CONDITION) TO EXAMINE THE LED INDICATORS ON SOME OF THE GENERATOR SUBASSEMBLIES. ACCORDING TO THE REPORT RECEIVED BY GMM, THE INSTALLER TRIPPED OVER HIS FEET AND FELL. HIS RIGHT FOREARM CAME INTO CONTACT WITH EXPOSED LIVE CIRCUITS, AND THE EMPLOYEE SUFFERED AN ELECTRIC SHOCK AND THIRD-DEGREE BURNS TO HIS FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458351 DISCOVERY RF180 SYSTEM, X-RAY, FLUOROSCOPIC JAA GENERAL MEDICAL MERATE S.P.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention