BEUDAMED
    FDA Adverse Event Summary report: N

    3085 SP SURGICAL TABLE

    MDR report key: 3983581 · Received July 1, 2014

    Report

    Report Number
    1043572-2014-00058
    Date Received
    July 1, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 1, 2014
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTRARY TO THE FACILITY'S REPORT, A STERIS SERVICE SPECIALIST ARRIVED AT THE FACILITY AND WAS INFORMED THE DOCTOR REQUESTED THE TABLE BE UNLOCKED IN ORDER TO ROTATE THE TABLE 180 DEGREES. WHEN THE FACILITY ATTEMPTED TO RELOCK THE TABLE, THE TABLE WAS UNRESPONSIVE TO HAND CONTROL COMMANDS. A STERIS SERVICE SPECIALIST INSPECTED THE TABLE AND HAND CONTROL AND FOUND THE RED BATTERY INDICATOR WAS FLASHING RED ON THE HAND CONTROL INDICATING THE TABLE BATTERIES NEEDED RECHARGING. THE SERVICE SPECIALIST THEN INSPECTED THE TABLE AND FOUND THE MOTOR BATTERIES WERE DEPLETED AND NOT HOLDING A CHARGE. TO REPAIR THE TABLE, BOTH THE MOTOR BATTERIES AND CONTROL BATTERIES WERE REPLACED, THE TABLE WAS TESTED AND FOUND TO BE OPERATING TO SPECIFICATION. THE TABLE WAS INSTALLED IN (B)(4) OF 2010 AND IS NOT UNDER STERIS SERVICE CONTRACT. SECTION 1-1 OF THE 3085 SP OPERATOR MANUAL STATES, "WARNING - DO NOT RELEASE FLOOR LOCKS WHILE PATIENT IS ON TABLE." WHILE ON-SITE, THE SERVICE SPECIALIST PROVIDED ADDITIONAL IN-SERVICE TRAINING TO THE USER FACILITY ON THE PROPER USE AND OPERATION OF THE SURGICAL TABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TABLE UNLOCKED AND ROTATED 180 DEGREES. THE OPERATOR ATTEMPTED TO RE-LOCK THE TABLE USING THE HAND CONTROL; HOWEVER, THE TABLE WAS UNRESPONSIVE TO HAND CONTROL COMMANDS. THE OPERATOR USED THE OVERRIDE SWITCHES TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385125 3085 SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other