BEUDAMED
    FDA Adverse Event Summary report: N

    3085SP SURGICAL TABLE

    MDR report key: 2113054 · Received June 3, 2011

    Report

    Report Number
    1043572-2011-00030
    Date Received
    June 3, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN REQUESTED TO INSPECT THE TABLE BUT THE USER FACILITY'S THIRD PARTY SERVICE PROVIDER REPORTED THEY HAD ALREADY REPLACED THE AC POWER CONTROL CABLE ASSEMBLY ("AC CABLE") AND AC POWER CORD, TESTED THE TABLE FUNCTIONS, AND PLACED THE TABLE BACK INTO SERVICE. THE TECHNICIAN WAS PROVIDED THE REPLACED PARTS AND PHOTOS TAKEN BEFORE AND AFTER THE REPAIR. STERIS ENGINEERING EVALUATED THE REPLACED AC CABLE AND AC POWER CORD AND FOUND EVIDENCE OF FLUID INTRUSION BY OBSERVING GREEN DISCOLORATION IN THE AC CABLE. THE FLUID INTRUSION CREATED AN ELECTRICAL SHORT CONDITION BETWEEN THE SUPPLY AND NEUTRAL PRONGS, CAUSING THE END OF THE AC POWER CORD TO MELT DUE TO HEAT. STERIS ENGINEERING ALSO EVALUATED THE PICTURES AND FOUND THE AC SOCKET FLIP DOWN COVER ("AC COVER") WAS MISSING; THE PURPOSE OF THE AC COVER IS TO PROTECT THE AC POWER CORD AND AC CABLE FROM FLUID INTRUSION. THE SURGICAL TABLE IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED BY THE USER FACILITY'S SERVICE PROVIDER. STERIS HAS RECOMMENDED THAT AN AC COVER BE INSTALLED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING PREPARATION FOR A PATIENT PROCEDURE, A NURSE OBSERVED A SMALL AMOUNT OF SMOKE AND SPARKING COMING FROM THE BASE OF THE SURGICAL TABLE. THE PATIENT WAS TRANSFERRED ONTO ANOTHER SURGICAL TABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO INJURIES WERE REPORTED TO HOSPITAL STAFF OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3085SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY 3085SP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other