BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX LCV+

    MDR report key: 3111804 · Received May 7, 2013

    Report

    Report Number
    9611343-2013-00016
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K960575
    Removal / Correction Number
    9611343-01/21/2013-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION HAS SHOWN THAT THIS MONITOR SUSPENSION WAS NOT MFG BY (B)(4) BUT BY GE HEALTHCARE. THIS INVESTIGATION SHOWED THE ISSUE HAD OCCURRED ON A CRT (CATHODE RAY TUBE) MONITOR SUSPENSION WHICH IS 9 YRS OLD. THE LOCKING MECHANISM AT THE PIVOT AXIS IS MADE WITH BUSH, BUSH CAP, NUT AND SCREW. FAILURE OF THE NUT WILL NOT LEAD TO THE IMMEDIATE FALL OF THE SUSPENSION AS IT WILL STILL BE HELD BY THE BUSH AND SCREW IN THE ABSENCE OF THE NUT. HOWEVER, IF IT IS NOT OBSERVED OVER A PROLONGED PERIOD OF TIME (THE NUT IS COVERED WITH A CAP AND NOT DIRECTLY VISIBLE) COMBINED WITH STRESSFUL USAGE, IT MAY LEAD TO THE FALL OF THE SUSPENSION. ON JUN 12, 2012 PREVENTIVE MAINTENANCE (PM) WAS PERFORMED ON THIS SITE. GE HEALTHCARE FIELD SERVICE ENGINEER CONFIRMED THAT THE NUT WAS IN PLACE AT THAT TIME AND NO ISSUE WAS REPORTED RELATED TO NUT LOOSENING. AS THE SCREW TIGHTNESS CHECK AT PIVOT AXIS IS NOT DEFINED IN THE PM CHECKLIST THERE IS A POTENTIAL FOR MISSING SCREW TIGHTNESS CHECK DUE TO THE COVERED NUT. GE HEALTHCARE FIELD SERVICE ENGINEER CONFIRMED THAT NO COLLISION WAS REPORTED IN THE NEAR PAST BEFORE THIS FINDING AND THAT THE CUSTOMER DID NOT HAVE ANY DIFFICULTY MOVING THE MONITOR SUSPENSION. GE HEALTHCARE MFG CONFIRMED THAT PREVAILING TORQUE NUT WITH PLASTIC INSERT WAS USED ON THE SCREW TO AVOID THE LOOSENING OF THE SCREW. NO LOCTITE IS USED DURING ASSEMBLY OF THE NUT AND SCREW. THERE IS A CHANCE OF INSUFFICIENT ENGAGEMENT OF THE PLASTIC INSERT (PART OF NUT AVAILABLE AT THE END) WITH SCREW DUE TO THE INSUFFICIENT LENGTH OF SCREW. CONTINUOUS VIBRATIONAL AND ROTATIONAL FORCE ON THE ARM BUSHING AND END PLUG MAY ACCELERATE THE AGING OF THE NUT, WHICH MAY LEAD TO THE REDUCTION IN ITS PRELOAD (AMOUNT OF FORCE ON THE BOLT AFTER TIGHTENING) OVERTIME AND LEAD TO LOOSENING OF THE NUT. GE HEALTHCARE FIELD SERVICE ENGINEER CORRECTED THE ISSUE ON THIS SPECIFIC SITE. A FIELD ACTION HAS BEEN INITIATED TO CORRECT THE ISSUE.

    Description of Event or Problem · 1

    A GE HEALTHCARE FIELD SERVICE REP NOTICED A MISSING NUT AND OFF CENTER INTERNAL RING ON THE THREE MONITOR SUSPENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199862 ADVANTX LCV+ SYSTEM, X-RAY, ANGIOGRAPHIC IZI GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1