BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1043572-2019-00020

    MDR report key: 8438128 · Received March 20, 2019

    Report

    Report Number
    1043572-2019-00020
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    February 22, 2019
    Report Date
    March 20, 2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE 3080 RL SURGICAL TABLE AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. UPON FURTHER INSPECTION, THE TECHNICIAN FOUND THAT THE PROTECTIVE GUARD FOR THE AUXILIARY OVERRIDE SWITCHES WAS MISSING, AND THE RUBBER COVERING ON THE TREND AUXILIARY OVERRIDE SWITCH WAS DAMAGED. BASED ON THE TECHNICIAN'S INSPECTION, THE ROOT CAUSE OF THE REPORTED EVENT CAN MOST LIKELY BE ATTRIBUTED TO THE TREND AUXILIARY OVERRIDE SWITCH BEING INADVERTENTLY ACTIVATED. THE CUSTOMER HAS ORDERED A NEW PROTECTIVE GUARD AND RUBBER COVERING FOR THE AUXILIARY OVERRIDE SWITCH PANEL. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR 3080 RL SURGICAL TABLE MOVED INTO TRENDELENBURG POSITION WITHOUT BEING COMMANDED TO DO SO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INJURY OR PROCEDURE DELAY WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1