BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPSIS

    MDR report key: 23074557 · Received September 17, 2025

    Report

    Report Number
    1931259-2025-00016
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 21, 2025
    Report Date
    December 11, 2025
    Manufacturer
    CERNER CORPORATION
    Product Code
    SAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CERNER HAS CONCLUDED ITS INVESTIGATION INTO THE HARDWARE MALFUNCTION THAT OCCURRED ON (B)(6) 2025. THE ISSUE WAS TRACED TO A THIRD-PARTY HEWLETT PACKARD (HP) FIRMWARE BUG AFFECTING AGING GEN8 HP SERVERS. CERNER HAS MADE CHANGES TO ENSURE MONITORING AND PATCHING AS A SHORT-TERM RESOLUTION AND WILL REPLACE HARDWARE IN 2026.

    Additional Manufacturer Narrative · 0

    ON AUGUST 21, 2025, CERNER'S INTERNAL MONITORING SYSTEMS IDENTIFIED A PROBLEM THAT CAUSED DELAYS IN SENDING SEPSIS NOTIFICATIONS, PROMPTING AN IMMEDIATE INVESTIGATION. THE DELAYS WERE CAUSED BY A HARDWARE MALFUNCTION INVOLVING THE SERVER'S DRIVE CONTROLLER, WHICH IMPAIRED THE SYSTEM'S ABILITY TO RELIABLY COLLECT, PROCESS, AND TRANSMIT DATA NECESSARY FOR TIMELY SEPSIS NOTIFICATION GENERATION. THE PROBLEM WAS RESOLVED BY RESTARTING THE AFFECTED SERVERS, WHICH RESTORED NORMAL NOTIFICATIONS OPERATIONS. THE INVESTIGATION REMAINS IN PROGRESS. CERNER WILL PROVIDE A FOLLOW-UP REPORT AT THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE SOFTWARE PRODUCT MENTIONED IN THIS MEDWATCH REPORT MAY NOT BE A MEDICAL DEVICE; HOWEVER, CERNER HAS CHOSEN TO FILE THIS MEDWATCH REPORT TO VOLUNTARILY NOTIFY THE FDA OF THE RESOLUTION OF A MALFUNCTION ASSOCIATED WITH THIS SOFTWARE PRODUCT. ON AUGUST 21, 2025, A SERVER MALFUNCTION DISRUPTED THE DATA PROCESSING FUNCTIONS REQUIRED FOR GENERATING TIMELY AND ACCURATE SEPSIS NOTIFICATIONS, RESULTING IN APPROXIMATELY SEVENTY MINUTES OF NOTIFICATION DELAYS. THE ISSUE HAS SINCE BEEN RESOLVED, AND NOTIFICATIONS ARE NOW FUNCTIONING AS EXPECTED. CERNER HAS NOT RECEIVED ANY REPORTS OF PATIENT INJURY AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731287 SEPSIS SOFTWARE DEVICE TO AID IN THE PREDICTION OR DIAGNOSIS OF SEPSIS SAK CERNER CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown