BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 12127987 · Received July 7, 2021

    Report

    Report Number
    3004972322-2021-00011
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    September 11, 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
    TH
    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. THIS ISSUE WAS INITIALLY IDENTIFIED AS A NON-REPORTABLE EVENT. 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 09/11/2019, 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 STUDY FOR PATIENT A, STUDY DETAILS FOR PATIENT B ARE 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
    1027774 SYNAPSE PACS SYNAPSE PACS LLZ N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1