BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG SPI2 HI RES PIP

    MDR report key: 1621930 · Received February 5, 2010

    Report

    Report Number
    2031963-2009-00067
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    November 26, 2007
    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
    IL, 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 (B)(6)2006 TO (B)(6)2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE BEING SUBMITTED UNDER EXEMPTION (B)(4). THERE ARE 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE GCJ.

    Description of Event or Problem · 1

    BURNING. OR (B)(6): SPI2 AND VE MONITOR (THE ONE FURTHEST FROM THE DOOR) HAS AN OPHIT THAT SMELLS LIKE IT IS BURNING, AND THEY ARE NOT ABLE TO GET DVI TO THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKG SPI2 HI RES PIP GCJ STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA