BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 12129271 · Received July 7, 2021

    Report

    Report Number
    3004972322-2021-00015
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    October 25, 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
    NY, US
    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. DURING A RETROSPECTIVE REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION. 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 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 TRIED TO PULL A REPORT FOR PATIENT A, NAME AND REPORT FOR PATIENT B IS DISPLAYED. USER ATTEMPTS AGAIN AND ERROR IS CORRECTED. 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
    1024106 SYNAPSE PACS SYNAPSE PACS LLZ N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1