BEUDAMED
    FDA Adverse Event Summary report: N

    3085SP SURGICAL TABLE

    MDR report key: 2570898 · Received May 11, 2012

    Report

    Report Number
    1043572-2012-00033
    Date Received
    May 11, 2012
    Date of Event
    April 13, 2012
    Report Date
    May 11, 2012
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE TECHNICIAN REMOVED AND INSPECTED THE POWER SUPPLY, CLEANED THE CONNECTIONS AND OBSERVED THAT THE POSITIVE BATTERY TERMINAL SHOWED SIGNS OF MELTING WHICH MAY HAVE CAUSED AN INTERNAL ELECTRICAL SHORT. THE TECHNICIAN REPLACED THE BATTERY, TESTED THE TABLE SUCCESSFULLY AND RETURNED IT TO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED. THE TABLE SUBJECT OF THE REPORTED EVENT IS UNDER STERIS SERVICE CONTRACT AND WAS LAST SERVICED DURING A ROUTINE PREVENTIVE MAINTENANCE VISIT ON (B)(6) 2012 WHERE THE TABLE WAS FOUND TO BE OPERATING PROPERLY, INCLUDING THE BATTERY CHARGING SYSTEM.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE ELECTRICAL GROUNDING OF THE 3085SP TABLE SET OFF THE OPERATING ROOM ELECTRICAL ALARMS. NO INJURY, DELAY IN PROCEDURE OR CANCELLATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1