BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3085SP SURGICAL TABLE

    MDR report key: 6905154 · Received September 29, 2017

    Report

    Report Number
    1043572-2017-00065
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    July 26, 2017
    Report Date
    September 29, 2017
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SURGICAL SERVICE REP ARRIVED ONSITE FOLLOWING THE RECEIPT OF THE USER FACILITY MEDWATCH AND DISCUSSED THE REPORTED EVENT WITH THE FACILITY'S BIOMEDICAL DEPARTMENT. THE BIOMED TECHNICIAN STATED THAT FOLLOWING THE REPORTED EVENT, HE INSPECTED THE TABLE AND FOUND THE TILT CYLINDER TO BE LEAKING. THE LEAKING TILT CYLINDER CAUSED THE UNINTENDED TABLE MOVEMENT AS DESCRIBED IN THE REPORTED EVENT. THE BIOMED TECHNICIAN REPLACED THE TILT CYLINDER AND RETURNED THE TABLE TO SERVICE. DURING THE TIME OF THE REPORTED EVENT, THE PATIENT MAY NOT HAVE BEEN PROPERLY SECURED TO THE SURGICAL TABLE SUBSEQUENTLY CAUSING THE PATIENT TO SLIDE WHEN THE TABLE'S UNEXPECTED MOVEMENT OCCURRED. THE OPERATOR MANUAL STATES (PP. 1-2), "UNANTICIPATED TABLE MOVEMENT COULD CAUSE PATIENT INJURY. PATIENT MUST BE SECURED TO THE TABLE IN ACCORDANCE WITH RECOMMENDED POSITIONING PRACTICES." THE OPERATOR MANUAL STATES (PP. 4-8), "WARNING - PERSONAL INJURY HAZARD: UNANTICIPATED TABLE MOVEMENT COULD CAUSE PATIENT INJURY. PATIENT MUST BE SECURED TO THE TABLE IN ACCORDANCE WITH RECOMMENDED POSITIONING PRACTICES." STERIS PROVIDED THE USER FACILITY WITH REFERENCES TO PRODUCT LABELING AND LITERATURE FOR THEIR AWARENESS TO ENSURE PROPER USE AND OPERATION OF THE SURGICAL TABLE ARE BEING FOLLOWED. THE USER FACILITY ACKNOWLEDGED THE RECEIPT OF THIS COMMUNICATION WITH STERIS. THE SURGICAL TABLE WAS INSTALLED IN 2009 AND IS SERVICED AND MAINTAINED BY THE USER FACILITY'S BIOMEDICAL DEPARTMENT. STERIS HAS NOT PERFORMED SERVICE ON THE SUBJECT TABLE SINCE 2010.

    Description of Event or Problem · 1

    REFERENCE MEDWATCH REPORT # MW5071537.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683801 3085SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1