BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3080 SURGICAL TABLE

    MDR report key: 1663067 · Received April 20, 2010

    Report

    Report Number
    1043572-2010-00026
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    March 5, 2010
    Report Date
    April 20, 2010
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS DISTRICT SERVICE MANAGER AND SERVICE TECHNICIAN INSPECTED THE TABLE FOUND IT TO BE IN PROPER MECHANICAL CONDITION. THE INSPECTION REVEALED THAT HALF OF THE VELCRO USED TO ATTACH THE X-RAY CENTER TOP SECTION TO THE TABLE TOP PAD WAS MISSING. WITHOUT THIS VELCRO THE TABLE TOP PAD WAS NOT PROPERLY ATTACHED TO THE X-RAY CENTER TOP, CAUSING THE PATIENT TO SLIDE OFF THE TABLE WHEN THE TABLE WAS PLACED INTO REVERSE ORIENTATION. STERIS HAS DETERMINED THE CAUSE OF THIS EVENT TO BE USER ERROR AS THE FACILITY DID NOT PROPERLY CHECK THE X-RAY TOP ACCESSORY OR THE TABLE TOP PAD PRIOR TO USE OF THE TABLE. THE EQUIPMENT OPERATOR MANUAL STATES ON PAGE 4-11, "WARNING - PERSONAL INJURY HAZARD: WHEN INSTALLING ANY TABLE ACCESSORY, CHECK FOR CORRECT ATTACHMENT AND TIGHTEN SECURELY. DO NOT USE WORN OR DAMAGED ACCESSORY. CHECK INSTALLATION BEFORE USING ANY ACCESSORY". THE SURGICAL TABLE IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY A THIRD PARTY. STERIS CONDUCTED AN IN-SERVICE TRAINING FOR HOSPITAL STAFF ON THE PROPER OPERATION OF THIS TABLE ON (B) (4) 2010.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PATIENT SLID OFF THE TABLE DURING A PATIENT PROCEDURE WHILE THE TABLE WAS IN THE REVERSE ORIENTATION, TRENDELENBURG FULL LEFT TILT POSITION. THE PATIENT WAS RESTRAINED WITH 1 RESTRAINING STRAP ACROSS HIS LOWER BODY. THE PATIENT RECEIVED A CT SCAN, CHEST X-RAY AND NEUROLOGICAL EXAM AND NO INJURIES WERE NOTED. STERIS CONTACTED THE HOSPITAL TO FOLLOW-UP ON THE PATIENT STATUS, HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3080 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY 3080

    Patients

    Seq Age Sex Outcome Treatment
    1 Other