BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 10381965 · Received August 7, 2020

    Report

    Report Number
    3004972322-2020-00004
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    June 12, 2020
    Report Date
    January 20, 2021
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
    Product Code
    LLZ
    UDI-DI
    00854904006008
    PMA / PMN Number
    K160108
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FUJIFILM INITIATED A RECALL ON 9/11/2020 TO CORRECT THE POWERJACKET ISSUE BY PROVIDING A SOFTWARE UPGRADE TO SYNAPSE PACS 5.7.200US. C&R REPORT (1000513161-09/17/2020-001-C) WAS SUBMITTED TO THE FDA. ON 01/16/2021, THE RECALL WAS CLASSIFIED BY FDA AS CLASS II AND ASSIGNED THE RECALL NUMBER Z-0878-2021. NO FURTHER INVESTIGATION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS EVALUATED AND REPLICATED IN THE FMSU LAB. THE CAUSE WAS TRACED TO A JAVA SCRIPT ERROR. THE ISSUE HAS BEEN RESOLVED; THE CUSTOMER'S SOFTWARE WAS UPGRADED. 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) 2020 FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) WAS NOTIFIED THAT THE SYNAPSE PACS SHOWS INCORRECT PATIENT STUDY/IMAGE IN THE POWERJACKET. THE ISSUE WAS REVIEWED AND ESCALATED TO THE ENGINEERING DEPARTMENT. ON (B)(6) 2020 A RISK ASSESSMENT WAS PERFORMED BY THE ENGINEERING DEPARTMENT TO INVESTIGATE RISK TO PATIENT SAFETY AND FMSU QUALITY AND REGULATORY AFFAIRS DEPARTMENTS WERE INFORMED OF THE SEVERITY. THERE WAS NO PATIENT INVOLVEMENT, 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
    844192 SYNAPSE PACS SYNAPSE PACS LLZ FUJIFILM MEDICAL SYSTEMS U.S.A., INC. N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1