BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBM SERVER

    MDR report key: 1599915 · Received February 8, 2010

    Report

    Report Number
    1064427-2009-00013
    Event Type
    Injury
    Date Received
    February 8, 2010
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    LLZ
    PMA / PMN Number
    K033825
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO PATIENT DATA LOSS, THERE WAS PATIENT INVOLVEMENT. HOWEVER, THERE IS NO INFORMATION ON PATIENTS AFFECTED OR IDENTIFIERS OF THOSE PATIENTS AT THIS TIME. LOSS OF PATIENT DATA COULD LEAD TO ADDITION DOSAGES OF RADIATION AS ANY STUDIES OR IMAGES MAY NEED TO BE RECAPTURED. THE (B) (4) SERVER IS THE DEVICE WHICH MALFUNCTIONED, HOWEVER, THE SERVER IS AN ACCESSORY TO THE OFFICEPACS SYSTEM. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THIS IS NOT AN IMPLANTABLE DEVICE AND IS NA. ACTUAL DEVICE WAS EVALUATED IN THE FIELD. THIS WAS A FIRMWARE RELATED ISSUE AND WAS RESOLVED BY UPDATING THE FIRMWARE AND REPLACING THE SYSTEM BOARD AND RAID CONTROLLER. AS PREVIOUSLY STATED, LOSS OF PATIENT DATA COULD LEAD TO ADDITION DOSAGES OF RADIATION AS ANY STUDIES OR IMAGES LOST MAY NEED TO BE RECAPTURED. THIS IS NOT A SINGLE USE DEVICE. (B) (4).

    Description of Event or Problem · 1

    IT WAS STATED BY THE INITIAL REPORTER THAT THE DRIVE FAILED ON THE SERVER AND THE SYSTEM WAS DOWN. AN ERROR WAS FOUND WITH ARRAY 0 - RAID 5, AND THE AMBER LIGHT WAS ILLUMINATED ON ONE OF THE DRIVES. AFTER FURTHER INVESTIGATION, THE DRIVE WAS REPLACED AND FIRMWARE WAS UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other