BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 10425992 · Received August 19, 2020

    Report

    Report Number
    3004972322-2020-00006
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    June 29, 2020
    Report Date
    January 20, 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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A SOFTWARE FIX FOR THE ISSUE IS AVAILABLE AND WILL BE PROVIDED TO THE CUSTOMER. 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) 2020 FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) SERVICE DEPARTMENT RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH THE SYNAPSE PACS POWERJACKET. THE POWERJACKET WAS SHOWING INCORRECT PATIENT STUDIES/IMAGES; ALL THE INFORMATION WAS CORRECT EXCEPT FOR THE IMAGES. THE CUSTOMER INDICATED THIS OCCURS A FEW TIMES A DAY. 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
    893490 SYNAPSE PACS SYNAPSE PACS LLZ N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1