BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBM SERVER

    MDR report key: 1599917 · Received February 8, 2010

    Report

    Report Number
    1064427-2010-00007
    Event Type
    Injury
    Date Received
    February 8, 2010
    Date of Event
    May 26, 2009
    Report Date
    May 26, 2009
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    LLZ
    PMA / PMN Number
    K033825
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 ADDITIONAL DOSAGE OF RADIATION AS ANY STUDIES OR IMAGES LOST 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. ACTUAL DEVICE WAS EVALUATED IN THE FIELD. EVALUATION SUMMARY REF (B) (4): THE ACTUAL DEVICE WAS EVALUATED IN THE FIELD. AFTER INVESTIGATING THE ISSUE WITH (B) (4), IT WAS DETERMINED THAT THE ROOT CAUSE WAS RELATED TO HAVING DOWN LEVEL FIRMWARE ON THE SERVER. (B) (4) INSTRUCTED THE USER TO APPLY THE CRITICAL FIRMWARE UPDATE AND REBUILD THE RAID ARRAY IN ORDER TO RECREATE THE LOGICAL DRIVES AND BRING BACK TO THE ONLINE STATE. STRYKER BEGAN REBUILDING THE LOGICAL DRIVES ON (B) (6) 2009 AND SHORTLY THEREAFTER, IT WAS DISCOVERED THAT THE RESTORATION OF DATA FROM GUARDIAN SERVICES DID NOT CONTAIN 100% OF THE ORIGINAL PATIENT DATA. AS PREVIOUSLY STATED, LOSS OF PATIENT DATA COULD LEAD TO ADDITIONAL DOSAGE 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

    THE CUSTOMER CONTACTED STRYKER STATING THAT THEIR OFFICEPACS SERVER WAS NOT ABLE TO BOOT INTO WINDOWS. AFTER INVESTIGATING THE ISSUE WITH (B) (4), IT WAS DETERMINED THAT THE ROOT CAUSE WAS RELATED TO HAVING DOWN LEVEL FIRMWARE ON THE SERVER.

    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 NA Other