BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4085 SURGICAL TABLE

    MDR report key: 7377306 · Received March 28, 2018

    Report

    Report Number
    1043572-2018-00028
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    March 14, 2018
    Report Date
    March 28, 2018
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE IS NOT UNDER STERIS SERVICE CONTRACT FOR MAINTENANCE ACTIVITIES. ALL MAINTENANCE ACTIVITIES ARE PERFORMED BY USER FACILITY ENGINEERING. THE TABLE WAS REMOVED FROM SERVICE FOLLOWING THE EVENT. FOLLOWING THE REPORTED EVENT, THE USER FACILITY'S MAINTENANCE STAFF CALLED INHOUSE ENGINEERING TO INSPECT THE TABLE AND THEY FOUND THAT THE TABLE'S FUSE HAD SHORTED. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE TABLE. THE TECHNICIAN REMOVED THE BASE COVERS AND OBSERVED FLUID AROUND THE TABLE'S POWER SUPPLY. ADDITIONALLY, THE TECHNICIAN NOTED THAT THE REAR SHROUD SUPPORT BRACKET, BASE COVER, AND COLUMN COVERS SHOWED EVIDENCE OF BENDING, RESULTING IN OPEN GAPS THAT WOULD HAVE ALLOWED FLUID INTRUSION. THE 4085 SURGICAL TABLE IS DESIGNED TO MEET IPX4 FLUID INGRESS STANDARDS, AND THE NORMAL FIT OF THE COVERS, ALONG WITH THE RTV SEALANT THAT IS APPLIED, WILL PREVENT FLUID INTRUSION. PER DISCUSSION WITH USER FACILITY PERSONNEL, HOUSEKEEPING SWABS THE TABLE'S BASE COVERS WITH A MOP. GIVEN THE OBSERVED DAMAGE TO THE BASE OF THE TABLE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS CAUSED BY MOP WATER ENTERING THE TABLE AND SHORTING THE INTERNAL COMPONENTS. THE 4085 SURGICAL TABLE OPERATOR MANUAL STATES, "THE PROPER METHOD FOR CLEANING A 4085 SURGICAL TABLE IS DOCUMENTED WITHIN THE OPERATOR MANUAL. THOSE STEPS SPECIFIC TO CLEANING THE TABLE BASE ARE AS FOLLOWS: CLEAN YOKE, SHROUDS AND ENTIRE BASE SURFACE AS FOLLOWS: HOLD CAN 6-8" (152-203 MM) FROM SURFACE AND SPRAY CLEANING FLUID LIBERALLY ON YOKE AND SHROUDS. AVOID SPRAYING IN DIRECTION OF CONNECTORS. WIPE SPRAYED SURFACES WITH A CLEAN, LINT-FREE CLOTH DAMPENED WITH WATER TO REMOVE CLEANING FLUID (DAMPENING CLOTH MINIMIZES STREAKING). WIPE CLEANED SURFACES AGAIN WITH A CLEAN, DAMP, LINT-FREE CLOTH TO REMOVE RESIDUE. REPEAT STEPS A, B, AND C FOR BASE SURFACE." THE TECHNICIAN REPAIRED THE TABLE'S BATTERY FUSE AND POWER SUPPLY, AND TESTED THE TABLE'S FUNCTIONALITY, AND RETURNED THE TABLE TO SERVICE. THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON PROPER CLEANING AND MAINTENANCE PRACTICES FOR THE 4085 SURGICAL TABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT SMOKE WAS EMITTING FROM THE COLUMN COVER OF THE 4085 SURGICAL TABLE. THE TABLE WAS NOT BEING UTILIZED AT THE TIME OF THE REPORTED EVENT AS ALL PROCEDURES HAD BEEN COMPLETED FOR THE DAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219650 4085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1