BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBL PACKAGE, BASIC ASSEMBLY IN CRATE

    MDR report key: 1972621 · Received January 18, 2011

    Report

    Report Number
    2031963-2011-00004
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. ACTUAL DEVICE WAS EVALUATED IN THE FIELD ON (B)(6) 2011. EVALUATION SUMMARY: AFTER AN ON-SITE EVALUATION BY A FIELD TECHNICIAN, IT WAS CONFIRMED THAT THERE WAS A HYDRAULIC LEAK. THE TABLE WILL BE SENT BACK IN-HOUSE FOR REPAIR. THE ROOT CAUSE FOR THE LEAK IS POSSIBLY DUE TO WORN OUT "USIT" WASHERS. THE MALFUNCTION OF A LEAK POSES A MODERATE RISK TO A USER FOR CAUSING A POTENTIAL SLIPPING HAZARD. OR IF THE LEAK WAS NOT NOTICED, IT CAN LEAD TO COMPLETE HYDRAULIC FLUID DRAIN CAUSING THE TABLE TO BE COMPLETELY NON-FUNCTIONAL FOR ARTICULATIONS (EXCEPT FOR SLIDE MECHANISM). HOWEVER, THIS SPECIFIC MALFUNCTION WAS IDENTIFIED PRIOR TO USE AND NO PTS WERE INVOLVED AND NO ADVERSE EVENTS WERE REPORTED. THIS TYPE OF NON-CONFORMANCE WILL BE MONITORED FOR ADVERSE TRENDS. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT A SURGICAL TABLE IN THE BIO MED SHOP WAS LEAKING HYDRAULIC FLUID. THERE WAS NO REPORTED PT INVOLVEMENT, AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL PACKAGE, BASIC ASSEMBLY IN CRATE FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA