BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBM SERVER X3650

    MDR report key: 1621923 · Received February 5, 2010

    Report

    Report Number
    1064427-2009-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    February 25, 2008
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    LLZ
    PMA / PMN Number
    K033825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE LLZ.

    Description of Event or Problem · 1

    (B) (6). (B) (6) MENTIONED THAT THE SITE WAS HAVING A PROBLEM WITH THE SERVER AND HAVING AN ERROR MESSAGE AFTER BOOTUP. IBM 3650 - MT# 7979 (B) (4) "!!!CRITICAL ERROR MEMORY RETENTION FAILURE, UNFLUSHED CACHE LOST!!!" (B) (4) CALLED IBM AND CONFERENCED (B) (6) AT THE SITE. IBM WILL SEND OUT A TECH. IBM WALKED HER THROUGH ON THE PHONE. SOUNDS LIKE A FIRMWARE ISSUE. (B) (4).... DOWNLOAD ISO FILE ON THE CD AND THEN TRIED REBOOTING THE SERVER THRU THAT CD. WE WERE ABLE TO GET THE SERVER UP AND RUNNING SO, THE CLINIC IS UP AND RUNNING. THEY ARE ABLE TO VIEW ALL THE IMAGES OKAY. ASKED (B) (6) TO COPY THE .ISO TO HER DESKTOP AND BURN IT ON THE CD AND THEN CALL US AND WE CAN CALL IBM FOR HER AND HAVE THE BATTERY PROBLEM RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBM SERVER X3650 LLZ STRYKER COMMUNICATIONS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other