BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT INDUSTRIES LLC

    MDR report key: 5707403 · Received June 8, 2016

    Report

    Report Number
    1450503-2016-00001
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    April 27, 2016
    Report Date
    June 8, 2016
    Manufacturer
    SUMMIT INDUSTRIES LLC.
    Product Code
    IXQ
    PMA / PMN Number
    K850118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SHORTLY THEREAFTER SUMMIT REPLACED THE ORIGINAL MODEL S210 TABLE WITH THE SAME TYPE TABLE SO THE ORIGINAL ONE COULD BE RETURNED TO THE FACTORY TO COMPLETE THE INVESTIGATION. UPON RETURN OF THE ORIGINAL TABLE W/ BUCKY, TESTS WERE PERFORMED TO VERIFY THE ROOT CAUSE(S) OF THE EVENT. SINCE IN THIS SUBJECT CASE THE MISWIRE APPLIED 120VAC TO THE BUCKY CABINET & THEN ONTO THE OUTSIDE METAL OF THE TABLE, WHICH WAS UNGROUNDED DUE TO THE PAINT BARRIER & LACK OF A LOCKWASHER BETWEEN THE POWER SUPPLY & THE TABLE BASE, A SHOCK HAZARD WAS PRESENT DURING THE INSTALLATION & RESULTED IN THE INSTALLER BEING SHOCKED. IN THIS MISWIRED CONDITION, THE BUCKY WOULD NOT OPERATE & THE INSTALLER WOULD NOT HAVE RELEASED THE TABLE FOR USE BY THE END USER UNTIL THE BUCKY OPERATION WAS CORRECTED. IT IS SUMMIT'S BELIEF THAT DURING THE INSTALLATION OF A TABLE WITH A MISWIRED BUCKY THAT THE INSTALLER WOULD CLEARLY NOTICE THAT THE BUCKY DOES NOT OPERATE & WOULD CORRECT THE MISWIRE AS PART OF THE INSTALLATION (AS HAPPENED IN THIS INSTANCE). REGARDING THE LIKELIHOOD OF THIS ELECTRICAL SHOCK EVENT REOCCURRING, PLEASE BE AWARE THAT SINCE 1988, SUMMIT HAS MANUFACTURED NEARLY (B)(4) OF THESE TABLES (MODEL S210/J005) MOST OF WHICH CONTAIN BUCKYS & THIS IS THE FIRST & ONLY EVENT OF ITS TYPE DURING THE PAST 28 YEARS OF PRODUCTION. DURING THE PAST MONTH, AS A PREVENTIVE MEASURE FOR THE PRESENT & FUTURE, SUMMIT HAS MADE SEVERAL DESIGN CHANGES TO THE TABLE TO IMPROVE GROUNDING CONTINUITY & IMPLEMENTED AN IMPROVED QC TEST PROCEDURE TO ASSURE GROUNDING CONTINUITY OF THE TABLE & BUCKY PRIOR TO APPROVAL FOR SHIPMENT. IN ADDITION, MANUFACTURING PERSONNEL WERE RETRAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, SUMMIT INDUSTRIES TECHNICAL SUPPORT RECEIVED A PHONE REPORT FROM AN INSTALLER (EMPLOYED BY (B)(4)) WHO OBSERVED THAT DURING THE INSTALLATION OF THE RADIOGRAPHIC TABLE, MODEL 210, WHICH INCLUDED A BUCKY (A BUCKY IS AN IMAGE RECEPTOR CABINET W/ ELECTRICALLY OPERATED RECIPROCATING GRID), THAT THE BUCKY DID NOT OPERATE AS RECEIVED & REQUESTED THAT SUMMIT SEND A PART, WHICH WAS SUSPECTED OF KEEPING THE BUCKY FROM OPERATING PROPERLY. THE NEXT DAY ((B)(6) 2016) THE INSTALLER CALLED BACK TO REPORT THAT THE REPLACEMENT PART DID NOT CORRECT THE PROBLEM & THAT WHILE TROUBLESHOOTING FURTHER, A COWORKER RECEIVED AN ELECTRICAL SHOCK WHEN HE TOUCHED THE TABLE & RELATED TUBESTAND AT THE SAME TIME. PER THE INSTALLER, THE COWORKER WAS NOT INJURED & DID NOT REQUIRE NOR RECEIVE ANY MEDICAL TREATMENT AS A RESULT OF THE EVENT & NEITHER THE INSTALLER NOR HIS COWORKER REPORTED THE EVENT TO THEIR MANAGER. SUBSEQUENT TROUBLE SHOOTING DISCOVERED A MISWIRE AT THE BUCKY TERMINAL STRIP WHICH HAD THE 120VAC CONNECTION REVERSED WITH THE GROUND CONNECTION. THE WIRING WAS CORRECTED & THE SYSTEM WAS TESTED & DETERMINED TO BE SAFE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362376 SUMMIT INDUSTRIES LLC 4 WAY FLOAT-TOP TABLE IXQ SUMMIT INDUSTRIES LLC. S210

    Patients

    Seq Age Sex Outcome Treatment
    1