BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 11118274 · Received January 5, 2021

    Report

    Report Number
    3004972322-2020-00010
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 4, 2020
    Report Date
    April 12, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FUJIFILM INITIATED A RECALL ON (B)(4) 2021 TO ALERT CUSTOMERS OF SEVERAL PATIENT MISMATCH ISSUES EXISTING IN ALL SYNAPSE PACS 5 VERSIONS UP TO 5.7.210. FUJIFILM SUBMITTED C&R REPORT (1000513161-03/11/2021-001-C) TO THE FDA, WHICH WAS CLASSIFIED AS CLASS II AND ASSIGNED RECALL NUMBER Z-1348-2021 ON 04/02/2021. 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. 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. 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) SERVICE DEPARTMENT RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS POWERJACKET. THE POWERJACKET WINDOW CAN BECOME OUT OF SYNC AND DISPLAY THE DETAILS FOR THE PREVIOUSLY LOADED PATIENT. ON DECEMBER 16, 2020 A RISK ASSESSMENT WAS PERFORMED TO INVESTIGATE THE RISK TO PATIENT SAFETY. 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
    15073 SYNAPSE PACS SYNAPSE PACS LLZ N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1