BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 12129328 · Received July 7, 2021

    Report

    Report Number
    3004972322-2021-00017
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    November 20, 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
    BD
    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. THIS ISSUE IS VERY RARE AND REQUIRES MANY TRIES WITH LARGE STUDIES TO REPRODUCE; IT IS CONSIDERED TO BE A VERY RARE OCCURRENCE IN A CLINICAL ENVIRONMENT. FUJIFILM HAS INITIATED A RECALL ON 3/2/2021 TO ALERT CUSTOMERS OF SEVERAL PATIENT MISMATCH ISSUES EXISTING IN ALL SYNAPSE PACS 5 VERSIONS. FUJIFILM SUBMITTED C&R REPORT 1000513161-03/11/2021-001-C TO FDA, WHICH HAS BEEN CLASSIFIED AS CLASS II AND ASSIGNED RECALL NUMBER Z-1348-2021. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: INTERNAL COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    ON 11/20/2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS A ISSUE NOTED IS AS FOLLOWS: WHEN THE USER ATTEMPTS TO OPEN A STUDY FOR PATIENT A, STUDY DETAILS FOR PREVIOUSLY VIEWED PATIENT'S NAME IS DISPLAYED. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026118 SYNAPSE PACS SYNAPSE PACS LLZ N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1