BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 10929489 · Received December 1, 2020

    Report

    Report Number
    3004972322-2020-00008
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 5, 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
    MA, 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. THIS IS A KNOWN ISSUE WITH AN ONGOING FIELD ACTION, AND THE CUSTOMER WAS PROVIDED THE FIELD ACTION VERIFICATION FORM, AND WILL BE SCHEDULED FOR AN UPGRADE. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    ON NOVEMBER 05, 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 INTERMITTENTLY DISPLAYED INCORRECT PATIENT INFORMATION. ON NOVEMBER 06, 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
    1395019 SYNAPSE PACS SYNAPSE PACS LLZ N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1