BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE SI

    MDR report key: 2479486 · Received February 23, 2012

    Report

    Report Number
    2126677-2012-00019
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    March 9, 2011
    Report Date
    March 14, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAA
    PMA / PMN Number
    K943805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS EVENT WAS ORIGINALLY REPORTED ON (B)(4) 2011, UNDER MDR 9611343-2011-00038. THE MFG SITE LOCATION IS BEING CORRECTED FROM GE MEDICAL SYSTEMS (B)(4) TO GE MEDICAL SYSTEMS (B)(4). THIS REPORT (MDR 2126677-2012-00019) REPLACES MDR 9611343-2011-00038. THE SUPPLIER OF THE PRESTIGE SI REVIEWED THE POTENTIAL FAILURES THAT WOULD CAUSE THE SYMPTOMS IDENTIFIED AT THE SITE. THE SUPPLIER WAS ABLE TO REPRODUCE THE SYMPTOMS REPORTED, AND DETERMINED THE MOST LIKELY ROOT CAUSE WAS AN INTERMITTENT FAILURE OF A TILT RELAY. THE SUPPLIER RECOMMENDED REPLACEMENT OF THREE RELAYS (2K4, 2K5 AND POWER VALIDATION). THIS CORRECTION WAS COMPLETED ON (B)(4) 2011, AT THE SITE. A REVIEW OF THE GE HEALTHCARE COMPLAINT HANDLING DATABASE (2009-2011, 24 MONTHS) AND SERVICE DATA WAS CONDUCTED TO DETERMINE IF A SYSTEMIC ISSUE EXISTS. NO ADD'L COMPLAINTS OR COMPONENT FAILURES MATCHING THE SYMPTOMS DESCRIBED IN THE REPORTED COMPLAINT WERE IDENTIFIED. NO ADD'L ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OPERATOR WAS ANGULATING THE TABLE ON A PRESTIGE SYSTEM FROM HORIZONTAL TO VERTICAL WITHOUT A PT. THE OPERATOR HEARD AN UNEXPECTED SOUND COME FROM THE SYSTEM. WHEN THE OPERATOR RELEASED THE TILT BUTTON ON THE CONSOLE, THE TABLE ANGULATION DID NOT STOP. THE OPERATOR PUSHED THE E-STOP (EMERGENCY STOP) ON THE CONSOLE, BUT THE TABLE ANGULATION STILL DID NOT STOP. FINALLY THE OPERATOR STOPPED THE POWER SUPPLY ON THE GENERATOR CONSOLE DESK WHICH DID STOP THE ANGULATION. AFTER SHUTTING DOWN AND RECYCLING THE POWER, THE SYSTEM WORKED NORMALLY. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE SI FLUOROSCOPIC X-RAY SYSTEM JAA GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other