BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNAPSE PACS

    MDR report key: 11185394 · Received January 18, 2021

    Report

    Report Number
    3004972322-2021-00002
    Event Type
    Injury
    Date Received
    January 18, 2021
    Date of Event
    December 29, 2020
    Report Date
    January 18, 2021
    Product Code
    LLZ
    UDI-DI
    00854904006008
    PMA / PMN Number
    K190232
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN. THE EF VALUE IS SELECTED BY THE USER VIA A DROP-DOWN MENU. ONCE THE DROP-DOWN MENU HAS BEEN SELECTED, THE EF VALUE CAN BE CHANGED BY THE UP AND DOWN ARROW KEYS. THE USER DID NOT CHANGE FOCUS FROM THE DROP-DOWN MENU IN THE ADVANCED REPORTING WINDOW TO THE VIEWER WINDOW BEFORE USING THE ARROW KEYS IN AN ATTEMPT TO MOVE TO THE NEXT IMAGE. THIS CAUSED THE SELECTED EF VALUE TO UNKNOWINGLY CHANGED. 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 (B)(6) 2021 FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) SERVICE DEPARTMENT RECEIVED A CUSTOMER NOTIFICATION REGARDING AN ADVERSE EVENT RELATED TO SYNAPSE PACS. TWO REPORTS CHANGED FROM A QUALITATIVE EJECTION FRACTION (EF) VALUE OF 55-60% TO ONE REPORTED AS <20%. THE ISSUE LED TO ONE PATIENT RECEIVING AN UNNECESSARY INVASIVE CORANARY ANGIO PROCEDURE. A SECOND PATIENT WAS UNAFFECTED BECAUSE THE ERROR WAS CAUGHT PRIOR TO ASSESSMENT. THE PATIENT HAS BEEN REPORTED TO US AS BEING HEALTHY WITH NO ISSUES AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80383 SYNAPSE PACS SYNAPSE PACS LLZ N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other