BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 12129429 · Received July 7, 2021

    Report

    Report Number
    3004972322-2021-00019
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    October 1, 2019
    Report Date
    July 7, 2021
    Product Code
    LLZ
    UDI-DI
    00854904006008
    PMA / PMN Number
    K160108
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS EVALUATED AND REPLICATED IN THE FMSU LAB; THE CAUSE WAS TRACED TO A SOFTWARE CONFIGURATION. THE ISSUE WAS RESOLVED AFTER UPGRADING TO VERSION 5.7 AND INSTALLING A SOFTWARE COMPONENT THAT ENHANCED THE CACHE MANAGEMENT. THIS ISSUE WAS INITIALLY IDENTIFIED AS A NON-REPORTABLE EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: INTERNAL COMPLAINT NUMBER COMP(B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS AN ISSUE NOTED THAT IS DESCRIBED BELOW: WHEN THE USER ATTEMPTS TO OPEN A REPORT FOR PATIENT A, STUDY DETAILS FOR PATIENT B ARE DISPLAYED. THIS ERROR IS EASILY IDENTIFIED SINCE NAME DISPLAYED DOES NOT MATCH. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023231 SYNAPSE PACS SYNAPSE PACS LLZ N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1