BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON RADIOLOGY

    MDR report key: 3815398 · Received March 27, 2014

    Report

    Report Number
    8022257-2014-00004
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    December 13, 2013
    Report Date
    December 13, 2013
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTING FACILITY INDICATED THAT THEY USE THE PRIORITY ALERT ICON FOR 'HOLD AND CALL' SITUATIONS, WHEREBY A PATIENT MUST REMAIN AT THE HEALTHCARE FACILITY FOR IMMEDIATE TREATMENT, OR UNTIL A PHYSICIAN HAS REVIEWED THE STUDY. MCKESSON MEDICAL IMAGING COMPANY COMPLETED AN INVESTIGATION AND CONCLUDED THAT THE SYSTEM MALFUNCTIONED. THE HIGH PRIORITY ALERT ICON IS ONLY DISPLAYED WHEN THERE IS ALSO A STAT STUDY PRESENT IN THE MCKESSON RADIOLOGY STUDY LIST. WHEN THE HIGH PRIORITY ALERT ICON IS NOT DISPLAYED AS INTENDED, THERE IS POTENTIAL FOR A DELAY IN CARE. MCKESSON MEDICAL IMAGING COMPANY CUSTOMER SUPPORT WILL WORK WITH POTENTIALLY AFFECTED CUSTOMERS TO APPLY A SOFTWARE UPDATE TO MCKESSON RADIOLOGY 12.0 FOR CORRECTING THE ERROR IDENTIFIED.

    Description of Event or Problem · 1

    THE REPORTING FACILITY INDICATED THAT THE HIGH PRIORITY ALERT ICON DID NOT DISPLAY ON THE MCKESSON RADIOLOGY STUDY LIST, AS EXPECTED. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179735 MCKESSON RADIOLOGY PICTURE ARCHIVING AND COMM. SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 12.0

    Patients

    Seq Age Sex Outcome Treatment
    1 UMK