BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE

    MDR report key: 10520409 · Received September 11, 2020

    Report

    Report Number
    9617251-2020-00002
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 17, 2020
    Report Date
    September 10, 2020
    Manufacturer
    SEDECAL SA
    Product Code
    KPR
    UDI-DI
    08436046002302
    PMA / PMN Number
    K042876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AS MENTIONED IN THE EVENT'S DESCRIPTION, THE CAUSE OF THE PROBLEM IS NOT RELATED, AT ALL, WITH A MALFUNCTION OF THE UNIT BUT A WRONG OR DEFECTIVE MAINTENANCE TASK. THE ASSEMBLY INSTRUCTIONS FOR COLLIMATOR ARE CORRECT AND CLEAR ENOUGH AND THEY ARE INCLUDED IN THE SYSTEM MANUAL AS WELL AS IN THE COLLIMATOR MANUAL. NO FURTHER ACTION IS REQUIRED FROM SEDECAL SIDE, JUST TO REPORT THE EVENT BY MEANS OF A MDR (3500A FORM).

    Description of Event or Problem · 1

    THE COLLIMATOR FELL OFF TUBEHEAD. THE COLLIMATOR WAS REATTACHED. THERE WAS NO INJURY. THE COLLIMATOR DID DETACH AND FALL ON THE TABLE DUE TO A DEFECTIVE REASSEMBLY AFTER A SERVICE MAINTENANCE TASK AS THE TECHNOLOGIST WAS POSITIONING THE COLLIMATOR DURING A PATIENT CHEST EXAM, THE COLLIMATOR FELL FROM ITS MOUNT ONTO THE TABLE. IMPORTANT INFORMATION: THE COLLIMATOR WAS REMOVED THE DAY BEFORE TO REPLACE TUBE. THE TUBE WAS THEN PUT BACK AS IT WAS NOT THE CAUSE OF THE PROBLEM. THE SET SCREW WAS NOT ALL THE WAY IN. FIELD ENGINEER WENT TO SITE AND SCREWED THE SCREW BACK IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990224 GE DIGITAL DIAGNOSTIC X-RAY SYSTEM KPR SEDECAL SA PROTEUS XR/F ET 08436046002302

    Patients

    Seq Age Sex Outcome Treatment
    1