BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER/DISINFECTOR

    MDR report key: 4706375 · Received April 20, 2015

    Report

    Report Number
    9680353-2015-00031
    Date Received
    April 20, 2015
    Date of Event
    March 25, 2015
    Report Date
    April 20, 2015
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS MONITORS RELEVANT WEBSITES AND SOCIAL MEDIA SOURCES PER OUR SOCIAL MEDIA POLICY TO IDENTIFY POTENTIAL COMPLAINTS. THROUGH THIS PROCESS, STERIS IDENTIFIED A POST FROM A USER UNDER THE NAME "(B)(6)" ABOUT A LEAKING WASHER. A STERIS SOCIAL MEDIA MONITORING REPRESENTATIVE REPLIED TO THE POST ON (B)(6) 2015: "DEAR (B)(6), WE CAME ACROSS YOUR POST ABOUT THE RELIANCE SYNERGY WASHER/DISINFECTOR. WE HAVE A DEDICATED SERVICE SUPPORT TEAM WHO CAN HELP. PLEASE PROVIDE US WITH YOUR PREFERRED METHOD OF CONTACT OR CALL 1-800-333-8828 FOR ASSISTANCE. THANK YOU." AS THE COMPLAINANT HAS NOT RESPONDED TO OUR FOLLOW UP POST, STERIS IS UNABLE TO DETERMINE IF THE REPORTED LEAK WAS A STEAM OR WATER LEAK. IT IS ALSO UNKNOWN IF AN INJURY, EVACUATION, AND/OR PROCEDURAL DELAY OR CANCELLATION OCCURRED. STERIS IDENTIFIED THIS POST THROUGH OUR SOCIAL MEDIA MONITORING PROCESS. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE POST AND ARE THEREFORE FILING THIS REPORT AS WE CANNOT DETERMINE IF THE EVENT MEETS THE REPORTING CRITERIA OUTLINED IN 21 CFR 803. A FOLLOW UP REPORT WILL BE FILED SHOULD WE RECEIVE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    SOCIAL MEDIA MONITORING IDENTIFIED THE FOLLOWING POST ON (B)(6): "DOOR LEAKS FROM TOP AND BOTTOM. ONLY ON HIGH SPEED DURING 180 PART OF CYCLE. SEEMS TO START HAPPENING AT AROUND 160 DEGREES. REPLACED DOOR CYLINDERS AND GASKETS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260863 RELIANCE SYNERGY WASHER/DISINFECTOR WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1