BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY HIGH RES

    MDR report key: 1620531 · Received February 5, 2010

    Report

    Report Number
    2031963-2009-00065
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    March 12, 2008
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    GCJ
    PMA / PMN Number
    K033132
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4).

    Description of Event or Problem · 1

    SERIOUS INJURY. OPERATING ROOM 12 VGA SIGNAL TO ALL MONITORS ARE INTERMITTENT. DOC ALLEGES PT HAD STROKE DUE TO STRYKER EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY HIGH RES GCJ STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other