BEUDAMED
    FDA Adverse Event Summary report: N

    3085SP SURGICAL TABLE

    MDR report key: 1685404 · Received May 12, 2010

    Report

    Report Number
    1043572-2010-00029
    Date Received
    May 12, 2010
    Date of Event
    April 14, 2010
    Report Date
    May 12, 2010
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND THAT THE FLOOR LOCK FEET WERE LOOSE AND OUT OF ADJUSTMENT AND THE RUBBER CYLINDERS OF THE FOOT ASSEMBLY WERE DETERIORATED. THE TECHNICIAN ADJUSTED THE FEET TO THE PROPER HEIGHT AND REPLACED THE FOOT ASSEMBLY. THE TABLE WAS RETURNED TO SERVICE. STERIS HAS DETERMINED THE CAUSE OF THIS EVENT TO BE USER ERROR AS THE HOSPITAL PERSONNEL UNLOCKED THE SURGICAL TABLE WITH THE PATIENT ON IT, WHICH IS WARNED AGAINST IN THE EQUIPMENT OPERATOR MANUAL (PP.1-1, 2-1): 'WARNING TIPPING HAZARD: DO NOT RELEASE FLOOR LOCKS WHILE PATIENT IS ON THE TABLE.' THE SURGICAL TABLE IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY THE FACILITY BIOMEDICAL DEPARTMENT. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE SURGICAL TABLE SINCE THE REPORTED EVENT. STERIS HAS SCHEDULED AN IN-SERVICE TRAINING FOR HOSPITAL STAFF REGARDING THE PROPER USE AND OPERATION OF THE TABLE ON MAY 19, 2010.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AT THE END OF A PATIENT PROCEDURE HOSPITAL PERSONNEL UNLOCKED THE TABLE WITH THE PATIENT IN REVERSE ORIENTATION AND THE TABLE TIPPED, CAUSING THE PATIENT TO SLIDE OFF THE TABLE. THE PATIENT WAS TRANSFERRED TO A STRETCHER, RECEIVED AN MRI AND CT SCAN AND WAS KEPT OVERNIGHT FOR OBSERVATION. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3085SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY 3085SP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other