BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 3282815 · Received August 1, 2013

    Report

    Report Number
    8022257-2013-00006
    Event Type
    Other
    Date Received
    August 1, 2013
    Date of Event
    July 2, 2013
    Report Date
    August 1, 2013
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL IMAGING COMPANY IDENTIFIED THAT THE 2 DISK HARD DRIVES THAT FAILED ON THE SAN WERE PART OF TEMPORARY STORAGE PRIOR TO PERMANENT ARCHIVAL WHICH MAY CONTAIN BOTH REPORTED AND UNREPORTED STUDIES. AT THIS SITE, THE MAJORITY OF THE LOST STUDIES WERE RETRIEVED FROM ARCHIVE. HOWEVER, FOR 47 STUDIES ONLY THE OLDER IMAGES EXISTED IN THE ARCHIVE ALTHOUGH ALL OF THE ASSOCIATED MOST CURRENT DIAGNOSTIC REPORTS WERE PRESENT. THE IMAGES THAT WERE MISSING WERE FOR 37 STUDIES FROM THE PERIOD 2006-2010, AND TEMPLATES FOR 10 STUDIES USED FOR PLANNING THE ORTHOPAEDIC SURGERY. FOR THE 10 ORTHOPAEDIC STUDIES, THE ORIGINAL/ACQUIRED IMAGES WERE NOT LOST. ONLY THE TEMPLATES WERE LOST. IF THESE 10 STUDIES ARE LATER VIEWED AS PRIORS, THE RADIOLOGIST IS ABLE TO VIEW THESE IMAGES AND THE CORRESPONDING REPORTS. IF AN ORTHOPAEDIC SURGEON IS TO VIEW THESE 10 STUDIES, THE TEMPLATES CAN BE RECREATED AND/OR THE SURGICAL NOTES/REPORT CAN BE VIEWED IN THE APPROPRIATE SYSTEM(S). MCKESSON REVIEWED THE SYSTEM'S LOGS AND DETERMINED THAT PREDICTIVE DRIVE FAILURE MESSAGES WERE SENT FROM BOTH DISK DRIVES PRIOR TO THEIR FAILURE BUT THE CUSTOMER DID NOT ACT ON THE MESSAGES AND ARRANGED TO REPLACE THE HARD DRIVES. AS A RESULT, THE DRIVES FAILED AND IMAGES ARE LOST. MCKESSON IS DETERMINED THAT THE PRODUCT PERFORMED AS INTENDED AND THE CUSTOMER HAS BEEN INFORMED TO PROMPTLY ACT ON PREDICTIVE SYSTEM FAILURE MESSAGES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING A MAINTENANCE CHECK PERFORMED BY A MCKESSON EMPLOYEE AT A CUSTOMER SITE, IT WAS DISCOVERED THAT 2 HARD DRIVES HAD FAILED ON THE CUSTOMER'S STORAGE AREA NETWORK (SAN). AS A RESULT, SOME IMAGES WERE LOST. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361575 HORIZON MEDICAL IMAGING LLZ MCKESSON MEDICAL IMAGING COMPANY 11.8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK