BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWP IRR

    MDR report key: 1621931 · Received February 5, 2010

    Report

    Report Number
    2031963-2009-00066
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    June 2, 2008
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    GCJ
    PMA / PMN Number
    K033132
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM 7/1/2006 TO 7/1/2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE BEING SUBMITTED UNDER EXEMPTION (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE GCJ.

    Description of Event or Problem · 1

    NO VIDEO. A (B) (4) OR9-SP ROUTER IS DOWN. (B) (4) PRODUCT# 0678000400ZRR....

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWP IRR GCJ STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA