BEUDAMED
    FDA Adverse Event Summary report: N

    3085SP SURGICAL TABLE

    MDR report key: 2810232 · Received October 31, 2012

    Report

    Report Number
    1043572-2012-00090
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN WENT ONSITE TO INSPECT THE TABLE AND FOUND THE TABLE IN THE LEVEL POSITION WITH NO HAND CONTROL. STERIS REQUESTED A HAND CONTROL FROM THE FACILITY. THE TECHNICIAN PERFORMED A FULL FUNCTIONAL TEST ON THE TABLE AND ALL ARTICULATIONS AND FOUND NO ISSUES. THE SERVICE TECHNICIAN DID REPORT THE HAND CONTROL EVIDENCED DAMAGE WHICH COULD HAVE LED TO FLUID INTRUSION. THIS COULD HAVE RESULTED IN THE REPORTED EVENT. STERIS RECOMMENDED THAT THE DAMAGED HAND CONTROL BE REPLACED.

    Description of Event or Problem · 1

    THE USER FACILITY REQUESTED STERIS INSPECT THE 3085 SURGICAL TABLE DUE TO A REPORTED PATIENT INCIDENT. ALLEGEDLY DURING A PATIENT PROCEDURE THE SURGICAL TABLE WAS IN A FULL FLEX POSITION AND WHEN COMMANDED, THE TABLE WOULD NOT MOVE OUT OF THE FLEX POSITION. THE HOSPITAL HAS BEEN UNWILLING TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; WE HAVE BEEN UNABLE TO CONFIRM IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR THE PATIENT WAS REQUIRED TO BE TRANSFERRED TO ANOTHER SURGICAL TABLE.

    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