BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 10407645 · Received August 14, 2020

    Report

    Report Number
    3004972322-2020-00005
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    April 29, 2020
    Report Date
    October 28, 2020
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
    Product Code
    LLZ
    UDI-DI
    00854904006008
    PMA / PMN Number
    K190232
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 22, 2020 FUJIFILM MEDICAL SYSTEMS USA, INC. RECEIVED A CLASSIFICATION COMMUNICATION FROM THE FDA FOR THE RECALL. UPDATED INFORMATION IS BEING PROVIDED IN SECTIONS H7 (RECALL), H9 (C&R NUMBER: 1000513161-09/16/2020-001-C, FDA RECALL NUMBER: Z-0282-2021) IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS DISCOVERED INTERNALLY; THIS SOFTWARE VERSION HAS NOT BEEN RELEASED TO ANY CUSTOMERS. THE CAUSE WAS TRACED TO INSUFFICIENT TESTING DURING DEVELOPMENT OF SOFTWARE VERSION. THE INCORRECT VALUE IS HIGHLY DETECTIBLE AND WOULD BE NOTICED BY THE CLINICIAN. THE ISSUE WILL BE RESOLVED PRIOR TO RELEASE TO CUSTOMERS. 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 THE FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) ENGINEERING DEPARTMENT INITIATED A COMPLAINT FOR AN INTERNAL ISSUE WHERE THE SYNAPSE PACS WAS SHOWING INCORRECT 3D SPHERE MAX VALUES FOR SPECIFIC CT STUDIES. THE 3D SPHERE MAX SHOULD GIVE A MAX DENSITY VALUE WITHIN THE SPHERE'S RANGE; HOWEVER THE VALUE SHOWN WAS MUCH HIGHER THAN EXPECTED. THE ISSUE IS NOT PRESENT WITH ANY OTHER DENSITY TOOLS. 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
    875042 SYNAPSE PACS SYNAPSE PACS LLZ FUJIFILM MEDICAL SYSTEMS U.S.A., INC. N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1