BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE PRECISION MPI

    MDR report key: 10021294 · Received May 4, 2020

    Report

    Report Number
    1000188474-2020-00001
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    March 11, 2020
    Report Date
    May 4, 2020
    Manufacturer
    NRT X-RAY A/S
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER EVALUATION OF ALL THE AVAILABLE INFORMATION, IT IS CONCLUDED THAT THE EVENT HAPPENED DUE TO AN OPERATOR ERROR. THE OPERATOR DROVE THE C-ARM INTO A MOVABLE FLOOR STANDING X-RAY SHIELD (NOT PART OF THE PRECISION MPI DEVICE). THIS CAUSED THE IMAGE INTENSIFIER TO PARTLY BREAK OFF ITS MOUNTING PLATE. NEITHER PATIENT NOR OPERATOR WAS HARMED. THE EVENT COULD HAVE BEEN AVOIDED IF THE OPERATOR HAD FOLLOWED THE WARNINGS AND INSTRUCTIONS IN THE OPERATORS MANUAL AND REMOVED THE FLOOR STANDING X-RAY SHIELD BEFORE MOVING THE C-ARM. THE SYSTEM HAS BEEN REPAIRED ON SITE AND IS IN SERVICE. THE MANUFACTURER EVALUATION IS BASED ON THE EVENT DESCRIPTION AND PHOTOS RECEIVED FROM SITE INCLUDING AN EVALUATION OF HISTORIC COMPLAINT DATA AND TRENDING. WE DO NOT FIND THAT THE DEVICE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    OPERATOR DROVE THE C-ARM INTO A MOVABLE FLOOR STANDING LEAD SHIELD STAND CAUSING THE IMAGE INTENSIFIER (II) TO BECOME LOOSE. THIS DID NOT CAUSE THE II TO FALL BUT RESULTED IN PHYSICAL DAMAGE TO THE EQUIPMENT. PATIENT OR OPERATOR WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483610 GE PRECISION MPI IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM JAA NRT X-RAY A/S 02980000 (XRF 141)

    Patients

    Seq Age Sex Outcome Treatment
    1