BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION XR/D

    MDR report key: 12104523 · Received July 1, 2021

    Report

    Report Number
    2126677-2021-00043
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 7, 2021
    Report Date
    August 23, 2021
    Product Code
    KPR
    PMA / PMN Number
    K012389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ORIGINALLY REPORTED OBSERVING OVERHEAD TUBE SUSPENSION (OTS) COLLIMATION AND ALIGNMENT ISSUES. THE GE SERVICE REPRESENTATIVE INVESTIGATED THE SYSTEM AND IDENTIFIED THE COLLIMATOR ROTATION LEVER WAS JAMMED BETWEEN THE COLLIMATOR AND THE COLLIMATOR MOUNTING PLATE WHICH IS A SYMPTOM OF A SERVICE REPRESENTATIVE NOT FULLY DEPRESSING THE DETENT LEVER WHILE INSTALLING THE COLLIMATOR TO THE MOUNTING FLANGE AS INSTRUCTED BY THE SERVICE MANUAL. THIS CUSTOMER SITE DOES NOT HAVE A SERVICE CONTRACT WITH GE HEALTHCARE AND THEREFORE PERFORMS ALL SERVICING TO THE SYSTEM THROUGH THEIR OWN IN-HOUSE SERVICE TEAM. DURING GE HEALTHCARE'S INVESTIGATION, THE CUSTOMER PROVIDED DETAILS THEY RECENTLY REMOVED THE COLLIMATOR FROM THIS SYSTEM DUE TO AN UNRELATED SERVICE ACTIVITY, BUT THEY WERE UNABLE TO PROVIDE THE DATE OR THE REASON FOR THE COLLIMATOR REMOVAL. IT WAS THEN CONCLUDED THE HOSPITAL'S IN-HOUSE SERVICE TEAM DID NOT FULLY DEPRESS THE LEVER WHEN THEY RE-INSTALLED THE COLLIMATOR. IN CONCLUSION, THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE A COLLIMATOR INSTALLATION ERROR BY THE HOSPITAL'S IN-HOUSE SERVICE REPRESENTATIVE. THIS ISSUE WAS CORRECTED BY THE GE SERVICE REPRESENTATIVE WHO REMOUNTED THE COLLIMATOR ACCORDING TO THE SERVICE MANUAL PROCEDURE. THE CUSTOMER WAS ALSO INFORMED TO BE SURE THE DETENT LEVER IS NOT PREVENTING THE COLLIMATOR FROM SEATING FULLY WHEN INSTALLING THE COLLIMATOR ANYTIME IN THE FUTURE.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED AND IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CUSTOMER AT (B)(6) MEDICAL CENTER IN THE USA REPORTED THEY WERE HAVING COLLIMATION AND ALIGNMENT ISSUES ON THEIR REVOLUTION XR/D FIXED RADIOGRAPHIC SYSTEM. THE GE FIELD ENGINEER ARRIVED AT THE SITE TO INVESTIGATE THE ISSUE AND IDENTIFIED THE COLLIMATOR ROTATION LEVER WAS JAMMED BETWEEN THE COLLIMATOR AND THE COLLIMATOR MOUNTING PLATE. THIS SYMPTOM CAN BE CAUSED BY A COLLIMATOR INSTALLATION ERROR OF NOT FULLY DEPRESSING THE COLLIMATOR ROTATION LEVER WHEN MOUNTING/INSTALLING THE COLLIMATOR TO THE MOUNTING FLANGE WHICH WAS IDENTIFIED AS A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001966 REVOLUTION XR/D SYSTEM, X-RAY, STATIONARY KPR 2213251

    Patients

    Seq Age Sex Outcome Treatment
    1