BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN

    MDR report key: 1621922 · Received February 5, 2010

    Report

    Report Number
    1064427-2009-00012
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    August 16, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    LMB
    PMA / PMN Number
    NA
    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 ARE 30 EVENT(S) ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE LMB.

    Description of Event or Problem · 1

    BACKUP ERROR. BACKUP JOB SETTING CHANGED TO "CONTINUE TRANSFER ON ERROR." PREVIOUS JOB ABORTED WHEN A FILE ACCESS ERROR OCCURRED AND PREVENTED US FROM COMPLETING THE BACKUP. RP: ALUC 08.22.06 12:22 EST (145.9:0.8) BACKUPS FAILED DURING TRANSFER YESTERDAY ((B) (6) 2006). THEN 171 OF 1688 FILES WERE TRANSFERRED: ALUC 08.22.06 11:35 EST (145.1:145.1) OPAD BACKUP FAILED LAST NIGHT WITH ERROR MESSAGE 'NETWORK ERROR OCCURRED DURING RECEIVE OPERATION.' ONLY 50 OUT OF 1792 FILES WERE TRANSFERRED. I HAVE RESUBMITTED THE JOB TO RUN AGAIN TODAY. 'UN-IDENTIFIED.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN LMB STRYKER COMMUNICATIONS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other