BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 10376510 · Received August 6, 2020

    Report

    Report Number
    3004972322-2020-00003
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    June 26, 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

    UPDATED INFORMATION IS PROVIDED IN SECTION H7, H9, AND H10 (ADDITIONAL NARRATIVE). 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 SOFTWARE CONFIGURATION. A BUG FIX WAS DEVELOPED AND PROVIDED TO FIX THE ISSUE. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: (B)(4).

    Description of Event or Problem · 1

    ON JUNE 26, 2020 FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) SERVICE DEPARTMENT RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS POWERJACKET. WHEN OPENING THE POWERJACKET AND SELECTING A PATIENT OFF THE WORKLIST, THE POWERJACKET DISPLAYED INCORRECT PATIENT INFORMATION. THE DOCTOR INDICATED THAT THE ISSUE OCCURRED AGAIN WHEN SELECTING ANOTHER PATIENT AND THE POWERJACKET AGAIN DISPLAYED A DIFFERENT PATIENT. THE FUJIFILM CUSTOMER SERVICE REPRESENTATIVE DID NOT IDENTIFY ANY ISSUES WITHIN THE IIS LOGS OF THE CUSTOMER AND THE ISSUE COULD NOT BE REPRODUCED. ON JULY 08, 2020 A RISK ASSESSMENT WAS PERFORMED TO INVESTIGATE THE RISK TO PATIENT SAFETY. 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
    836203 SYNAPSE PACS SYNAPSE PACS LLZ FUJIFILM MEDICAL SYSTEMS U.S.A., INC. N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1