BEUDAMED
    FDA Adverse Event Summary report: N

    4085 SURGICAL TABLE

    MDR report key: 3023856 · Received March 27, 2013

    Report

    Report Number
    1043572-2013-00031
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE TABLE AND REPORTED THAT SEVERAL HEAT SINKS IN THE POWER SUPPLY WERE BURNT. HE ALSO STATED THAT FLUID (3-4 TEASPOONS) WAS FOUND UNDER THE POWER SUPPLY, IN ADDITION TO WHAT HE BELIEVED TO BE FLUID RESIDUE ON THE UNDERSIDE OF THE BASE SHROUD AND TOP COLUMN. NO OTHER DAMAGE WAS REPORTED. THE BIOMED EMPLOYEE STATED THAT THE PRECEDING PROCEDURE WAS A 'VERY WET CASE'. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY AND SIDE MOTOR CABLE. HE ALSO REPLACED THE SHROUDS AND SILICONE SECTIONS. THE TABLE WAS CONFIRMED OPERATIONAL AND RETURNED TO SERVICE. THE TABLE WAS INSTALLED ON (B)(6) 2013 WITHOUT ANY ISSUE.

    Additional Manufacturer Narrative · 1

    STERIS WAS MADE AWARE OF THIS EVENT ON (B)(6) 2013 AND FILED AN MDR (1043572-2013-00031) ON (B)(4) 2013. UPON RECEIPT OF THE USERS MEDWATCH ON (B)(4) 2013 WE CONTACTED THE FACILITY AND CONFIRMED THERE WAS ONLY ONE EVENT; THIS IS THE EVENT REPORTED IN OUR MDR (1042572-2013-00031).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A 'BURNING SMELL' COMING FROM THEIR 4085 SURGICAL TABLE FOLLOWING A WET CASE. THE FACILITY'S BIOMED EMPLOYEE WAS IN THE AREA WHEN THE SMELL OCCURRED. THE TABLE WAS IMMEDIATELY UNPLUGGED. THERE WAS NO INITIATION OF THE SPRINKLER SYSTEM AND THE FIRE DEPARTMENT WAS NOT NOTIFIED. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED. NO INJURY TO HOSPITAL STAFF OR PATIENTS REPORTED.

    Description of Event or Problem · 1

    REFERENCE MEDWATCH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125613 4085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1