BEUDAMED
    FDA Adverse Event Other Summary report: N

    SKYTRON

    MDR report key: 771900 · Received August 10, 2006

    Report

    Report Number
    1825014-2006-00008
    Event Type
    Other
    Date Received
    August 10, 2006
    Date of Event
    July 26, 2006
    Report Date
    August 9, 2006
    Manufacturer
    KMW GROUP, SKYTRON DIV
    Product Code
    BWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2006, VICTORY PRODUCTS RECEIVED A CALL FROM HOSP AND THE REPORTED SMOKE EMANATING FROM THE POWER CORD OF A 6500 TABLE. THE SKYTRON REP PROCEEDED TO THE FACILITY TO PERFORM AN EVALUATION OF THE SITUATION. HIS PRELIMINARY EXAMINATION REVEALED A BURNT OR MELTED POWER CORD ASSEMBLY. THE CAUSE OF THE BURNT POWER CORD APPEARS TO HAVE BEEN INDUCED BY OXIDATION OR CORROSION OF THE TABLE BASE POWER CORD RECEPTABLE CONNECTOR PINS. THE INCREASED RESISTANCE LEAD TO EXCESSIVE HEAT AND SUBSEQUENT MELTING OF THE FEMALE END OF THE POWER CORD. DURING HIS INVESTIGATION, HE LEARNED THAT THE CLEANING PRACTICES OF THE FACILITY LIKELY CAUSED THE CORROSION TO THE CONNECTOR. THE CLEANING STAFF SPRAY CLEANING FLUID DIRECTLY ONTO THE BASE OF THE TABLE AND CONNECTORS AGAINST THE MFRS MAINTENANCE AND USAGE INSTRUCTIONS. ROUTINE PREVENTATIVE MAINTENANCE BY IN HOUSE PERSONNEL DID NOT DETECT THE CORROSION OR REPLACE THE PARTS. ADDITIONALLY, SKYTRON REQUIRES THAT WHEN USING SPRAY CLEANERS DO NOT SPRAY FLUIDS DIRECTLY INTO A ELECTRICAL CONNECTORS OR MICRO SWITCHES. THIS INFO IS CLEARLY STATED IN THE PRODUCT'S OPERATORS MANUAL. SKYTRON IS WORKING WITH VICTORY PRODUCTS AND ALEXANDRIA HOSP TO RETROFIT THE POWER CORD TO A SEALED TYPE NON DETACHABLE STYLE DUE TO THEIR UNWILLINGNESS TO CHANGE CLEANING PRACTICES. WE ARE STILL IN THIS PROCESS AND WE WILL FILE A FOLLOW UP REPORT WHEN COMPLETE WITH CONCLUSIVE ACTION.

    Description of Event or Problem · 1

    EXCESSIVE SMOKE EMANATING FROM 120 VOLT POWER CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON SURGICAL TABLE BWN KMW GROUP, SKYTRON DIV ELITE 6500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other