BEUDAMED
    FDA Adverse Event Summary report: N

    CMAX SURGICAL TABLE

    MDR report key: 1863045 · Received October 9, 2010

    Report

    Report Number
    1043572-2010-00073
    Date Received
    October 9, 2010
    Date of Event
    June 24, 2010
    Report Date
    October 8, 2010
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GDC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE SURGICAL TABLE AND WAS ABLE TO DUPLICATE THE REPORTED EVENT. THE TECHNICIAN REPLACED THE HYDRAULIC MANIFOLD AND PLACED THE TABLE BACK IN SERVICE. THE HYDRAULIC MANIFOLD SUBJECT OF THIS EVENT WAS RETURNED TO STERIS FOR EVALUATION, HOWEVER THE MANIFOLD COULD NOT BE EVALUATED DUE TO DAMAGE AND DEBRIS ON THE MANIFOLD NOTED UPON RECEIPT; THE RESULTS OF AN EVALUATION WOULD NOT BE RELIABLE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE TABLE SINCE THE EVENT OCCURRED AND STERIS HAS DETERMINED THIS TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHEN HOSPITAL PERSONNEL ATTEMPTED TO POSITION THE PATIENT FOR SURGERY, THE SURGICAL TABLE WOULD NOT ARTICULATE AS COMMANDED. THE PATIENT WAS TRANSFERRED TO ANOTHER TABLE WHICH CAUSED A DELAY IN THE START OF THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT OR HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CMAX SURGICAL TABLE SURGICAL TABLE GDC STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other