BEUDAMED
    FDA Adverse Event Summary report: N

    AMSCO 2080RC SURGICAL TABLE

    MDR report key: 4427613 · Received January 16, 2015

    Report

    Report Number
    1043572-2015-00007
    Date Received
    January 16, 2015
    Date of Event
    December 19, 2014
    Report Date
    January 16, 2015
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 (B)(6) ABOUT LIMITED FUNCTIONALITY OF A 2080RC SURGICAL TABLE. A STERIS SOCIAL MEDIA MONITORING REPRESENTATIVE REPLIED TO THE POST ON 12/22/2014: "DEAR BIOMEDTEC, WE CAME ACROSS YOUR POST ABOUT THE AMSCO 2080 RC SURGICAL TABLE. 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 THIS TABLE WAS BEING USED DURING A PATIENT PROCEDURE WHEN THE REPORTED TABLE MALFUNCTIONS OCCURRED.

    Description of Event or Problem · 1

    SOCIAL MEDIA MONITORING IDENTIFIED THE FOLLOWING POST ON (B)(6): "OK HERE IS THE DILEMMA. ONLY HALF THE FUNCTIONS WILL WORK, THE REMOTE CONTROL HAS ALREADY BEEN REPLACED. HERE IS WHAT I MEAN: 1. IT WILL TILT TO ONE SIDE BUT WONT COME BACK OR TILT TO THE OTHER SIDE. 2. WILL LOWER THE HEAD BUT WILL NOT RAISE IT. 3. LEG WILL LOWER BUT WILL NOT RAISE IT. WE FOUND SOME BURNED OUT RELAYS, SO WE REPLACED ALL 13 OF THEM FOR GOOD MEASURE. THE PUMP CAN BE HEARD TURNING ON BUT WILL NOT ENGAGE THE FUNCTION. ALSO THE MANUAL THAT WE HAVE IS FOR THE TABLE WITH THE OLDER STYLE REMOTE. AND WE WERE LOOKING FOR THE WIRING SCHEMATICS FOR THE NEW STYLE REMOTE TABLES. BEST REGARDS, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39413 AMSCO 2080RC SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1