BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4085 SURGICAL TABLE

    MDR report key: 8529260 · Received April 18, 2019

    Report

    Report Number
    1043572-2019-00027
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    February 27, 2019
    Report Date
    April 18, 2019
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE SURGICAL TABLE AND FOUND EVIDENCE OF DAMAGE TO THE TABLE'S COLUMN COVERS. PER THE TECHNICIAN'S INSPECTION, THE COLUMN COVERS DID NOT BREAK INTO PIECES AS INITIALLY REPORTED BY FACILITY PERSONNEL, BUT RATHER THE TWO COVER HALVES HAD PARTIALLY SEPARATED AND A PORTION OF THE COLUMN COVER HAD BECOME BENT. TO ADDRESS THE ISSUE, THE TECHNICIAN ORDERED NEW COLUMN COVERS. THE FACILITY'S BIOMED DEPARTMENT ELECTED TO REPAIR THE SURGICAL TABLE RATHER THAN STERIS PERFORMING THE REPAIR. THE DAMAGE OBSERVED TO THE COLUMN COVERS IS ATTRIBUTED TO USER FACILITY PERSONNEL STORING ITEMS ON THE BASE OF THE TABLE. AS FACILITY PERSONNEL STORED ITEMS ON THE BASE OF THE TABLE AND NEAR/AROUND THE COLUMN COVERS, THE ITEMS BECAME CAUGHT ON THE COLUMN COVERS WHEN ARTICULATING THE TABLE AND SUBSEQUENTLY THE COVERS BECAME BENT OVER TIME. ALL ITEMS SHOULD BE CLEAR OF THE TABLE BASE AND COLUMN PRIOR TO A POWER-DRIVEN MOVEMENT (UP AND DOWN). THE 4085 SURGICAL TABLE IS MANUFACTURED WITH A WARNING LABEL THAT IS DIRECTLY APPLIED TO THE TABLE BASE COVER. THIS LABEL CONTAINS A PICTORIAL GRAPHIC INDICATING ITEMS SHOULD NOT BE STORED UPON THE TABLE BASE. THE LABEL ALSO INCLUDES THE FOLLOWING TEXT: "WARNING - DO NOT STORE ITEMS ON BASE - PERSONAL INJURY HAZARD/EQUIPMENT DAMAGE HAZARD: FAILURE TO KEEP ALL PERSONNEL AND EQUIPMENT CLEAR OF THE TABLE BEFORE ACTUATING ANY INERTIA-DRIVEN OR POWER-DRIVEN MOVEMENT COULD RESULT IN TABLE DAMAGE AND/OR PERSONAL INJURY". THE USER FACILITY DOES NOT HAVE A SERVICE AGREEMENT WITH STERIS; THE FACILITY'S BIOMED DEPARTMENT IS RESPONSIBLE FOR PERFORMING ALL SERVICE ACTIVITIES. PRIOR TO RECEIPT OF THE MEDWATCH REPORT, STERIS HAD NOT BEEN CONTACTED REGARDING ANY ISSUES WITH THIS SURGICAL TABLE SINCE (B)(6) 2017. A STERIS ACCOUNT MANAGER OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE SURGICAL TABLE, WITH FOCUS ON ENSURING THAT ITEMS ARE NOT STORED ON THE BASE OF THE TABLE AND THE USER FACILITY HAS ACCEPTED THIS OFFER. THE IN-SERVICE TRAINING WILL BE PERFORMED ON MAY 2, 2019.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT # (B)(4), THAT DURING A PATIENT PROCEDURE THEIR 4085 SURGICAL TABLE'S COLUMN COVERS BROKE INTO PIECES. THE PATIENT WAS STABILIZED BY FACILITY PERSONNEL AND TRANSFERRED TO ANOTHER TABLE CAUSING A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO INJURIES ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318970 4085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1