BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY DIGITAL R&F

    MDR report key: 5013350 · Received August 19, 2015

    Report

    Report Number
    2126677-2015-00015
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 31, 2015
    Report Date
    July 31, 2015
    Manufacturer
    WSO GE MEDICAL SYSTEMS, LLC
    Product Code
    IXR
    PMA / PMN Number
    K973039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION HAS CONCLUDED AND THE CAUSE OF THIS EVENT WAS DETERMINED TO BE WEAR OF THE LOCKING MECHANISM. THE FOOT REST ASSOCIATED WITH THIS EVENT WAS INSTALLED ON THIS SYSTEM FOR SEVENTEEN YEARS. IT WAS CONFIRMED THAT DUE TO THIS WEAR, THE LATCH WAS ABLE TO TRAVEL BEYOND ITS LIMIT WHICH LEAD TO INEFFECTIVE LOCKING OF THE FOOT REST.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A FLUOROSCOPY EXAM, A PATIENT STEPPED ONTO THE FOOT REST WHEN IT DETACHED FROM THE TABLE CAUSING THE PATIENT TO FALL APPROXIMATELY 5 INCHES TO THE FLOOR. THE PATIENT COMPLAINED OF ARM AND NECK PAIN AND WAS TAKEN TO THE EMERGENCY DEPARTMENT FOR AN X-RAY OF THE ELBOW AND LUMBAR SPINE. THE X-RAYS WERE NEGATIVE AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549982 LEGACY DIGITAL R&F TABLE, RADIOGRAPHIC, TILTING IXR WSO GE MEDICAL SYSTEMS, LLC 46-262751G7

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR