BEUDAMED
    FDA Adverse Event Summary report: N

    ORTHOVISION TABLE

    MDR report key: 2983211 · Received February 28, 2013

    Report

    Report Number
    1043572-2013-00017
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 28, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    JEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND THAT THE TABLE TOP WOULD DRIFT SLOWLY DOWN DUE TO LEAKAGE WITHIN THE LIFT CYLINDER WHEN PATIENT WEIGHT WAS APPLIED. THE USER FACILITY STATED TO THE STERIS TECHNICIAN THAT THEY WERE AWARE OF THE NEED TO REPAIR THE TABLE BUT CONTINUED TO USE IT. THE TECHNICIAN STATED THAT THEY WERE USING SOME UNSPECIFIED MEANS OF BLOCKING/STOPPING THE TABLE DRIFT. THE TECHNICIAN REPLACED THE LIFT CYLINDER, TESTED THE TABLE AND CONFIRMED IT TO BE OPERATIONAL. THE TABLE IS NOT UNDER STERIS SERVICE CONTRACT AND IS SERVICED AND MAINTAINED BY THE USER FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHEN A PATIENT IS PLACED ON THE ORTHOVISION TABLE IT WOULD SLOWLY DRIFT DOWN. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88650 ORTHOVISION TABLE TABLE JEB STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1