BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 3245720 · Received July 22, 2013

    Report

    Report Number
    8022257-2013-00004
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    May 1, 2013
    Report Date
    July 22, 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

    AT THIS TIME, THE INVESTIGATION IS STILL ACTIVE. MCKESSON IS INVESTIGATING THE EVENT DISCOVERED AT THIS SITE TO DETERMINE THE ROOT CAUSE. ONCE THE INVESTIGATION IS COMPLETE, MCKESSON WILL SUBMIT A FOLLOW UP REPORT WITH THE EVALUATION SUMMARY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING A MAINTENANCE CHECK PERFORMED BY A MCKESSON EMPLOYEE AT A CUSTOMER SITE ((B)(6)) DISCOVERED THAT STUDIES PERFORMED BY THE CUSTOMER ON (B)(6) 2013 FOR 3 DIFFERENT PATIENTS HAD MISSING IMAGES, AS FOLLOWS: 1 IMAGE OUT OF 67 ULTRASOUND IMAGES; 1 IMAGE OUT OF 12 ULTRASOUND IMAGES AND 1 IMAGE OUT OF 227 CT IMAGES. THE MISSING IMAGES RESULTED IN A FAILURE TO ARCHIVE THESE 3 STUDIES. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341869 HORIZON MEDICAL IMAGING LLZ MCKESSON MEDICAL IMAGING COMPANY 11.6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK