BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1043572-2018-00052

    MDR report key: 7650954 · Received June 29, 2018

    Report

    Report Number
    1043572-2018-00052
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    May 30, 2018
    Report Date
    June 29, 2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE EVENT, THE PATIENT WAS NOT PROPERLY SECURED TO THE SURGICAL TABLE SUBSEQUENTLY CAUSING THE PATIENT TO SLIDE WHEN THE TABLE'S UNEXPECTED MOVEMENT OCCURRED. NO PATIENT RESTRAINTS WERE USED TO KEEP THE PATIENT FROM SLIDING. 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". FOLLOWING THE EVENT, FACILITY PERSONNEL TESTED THE FUNCTION AND OPERATION OF THE TABLE AND WERE UNABLE TO DUPLICATE THE UN-COMMANDED TABLE MOVEMENT. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE SURGICAL TABLE AND FOUND THE TABLE TO BE OPERATING PROPERLY. THE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED MOVEMENT. THE TECHNICIAN REMOVED THE TABLE'S COLUMN SHROUD TO INSPECT ALL WIRING AND FOUND THE TABLE TO BE OPERATING ACCORDING TO SPECIFICATION; NO REPAIRS WERE REQUIRED. ADDITIONALLY, THE TECHNICIAN INSPECTED THE HAND CONTROL AND AUXILIARY HAND CONTROL AND FOUND BOTH TO BE OPERATING ACCORDING TO SPECIFICATION. BASED ON THE DESCRIPTION OF THE EVENT, THE REPORTED EVENT APPEARS TO BE ATTRIBUTED TO A POWERED MOVEMENT VIA INADVERTENT HAND CONTROL ACTIVATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING THE CONCLUSION OF A PATIENT PROCEDURE THE 4085 GENERAL SURGICAL TABLE BEGAN TO MOVE INTO TRENDELENBURG POSITON WITHOUT BEING COMMANDED TO DO SO CAUSING THE PATIENT TO BEGIN TO SLIDE OFF THE TABLE. FACILITY PERSONNEL STABILIZED THE PATIENT AND UTILIZED THE HAND CONTROL TO BRING THE TABLE BACK INTO THE DESIRED POSITION. ONCE THE PATIENT WAS STABILIZED THEY WERE TRANSFERRED TO ANOTHER TABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INJURY TO THE PATIENT WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1