BEUDAMED
    FDA Adverse Event Summary report: N

    3085SP SURGICAL TABLE

    MDR report key: 2193364 · Received August 5, 2011

    Report

    Report Number
    1043572-2011-00036
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 5, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE TABLE, TESTED ALL FUNCTIONS, AND FOUND THE TABLE TO BE PROPERLY OPERATING. THE SURGICAL TABLE IS NOT UNDER STERIS MAINTENANCE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY THE FACILITY BIOMEDICAL DEPARTMENT. THE OPERATOR MANUAL CLEARLY STATES TO NOT DISENGAGE THE TABLE FLOOR LOCKS WITH A PATIENT ON THE TABLE. SPECIFICALLY, PP 1-1 AND 2-1 STATES "WARNING - TIPPING HAZARD- DO NOT RELEASE FLOOR LOCKS WHILE PATIENT IS ON TABLE", AND ON PP 2-3 "SECTION 2.2.1 PREVENT POSSIBLE TIPPING DO NOT RELEASE FLOOR LOCKS WHILE PATIENT IS ON TABLE". ADDITIONALLY, A LABEL PRESENT ON THE TABLE BASE STATES "TIPPING HAZARD - DO NOT RELEASE FLOOR LOCKS WHILE PATIENT IS ON TABLE". IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THIS TABLE WILL BE CONDUCTED ON (B)(4) 2011.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT HOSPITAL STAFF UNLOCKED THE TABLE FLOOR LOCKS WITH A PATIENT ON THE TABLE AND WHILE ROTATING THE TABLE IT STARTED TO TIP. HOSPITAL STAFF RETURNED THE TABLE TO LEVEL, LOCKED THE FLOOR LOCKS AND COMPLETED THE PROCEDURE 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

    Patients

    Seq Age Sex Outcome Treatment
    1