BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-TASK ARMBOARD WITH 1" BLACK PAD

    MDR report key: 1621929 · Received February 5, 2010

    Report

    Report Number
    2031963-2009-00055
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    May 10, 2007
    Report Date
    February 5, 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
    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 PART OF A RETROSPECTIVE SUMMARY REPORT (B)(4). THERE ARE 3 EVENT(S) ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE FQO.

    Description of Event or Problem · 1

    DID NOT FUNCTION AS EXPECTED. ARM REST DID NOT LOCK IN PLACE. PATIENT ON THE TABLE AND THE ARM REST FELL OFF TABLE. PATIENT WAS NOT HARMED (POTENTIAL FOR PATIENT TO FALL OFF AND HAVE INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-TASK ARMBOARD WITH 1" BLACK PAD FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA