BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAGIO BREAST IMAGING SYSTEM, MODEL 9100

    MDR report key: 22778874 · Received August 11, 2025

    Report

    Report Number
    3014755924-2025-04001
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    April 3, 2025
    Report Date
    August 11, 2025
    Manufacturer
    SENO MEDICAL, INC.
    Product Code
    QNK
    UDI-DI
    00864802000459
    PMA / PMN Number
    P200003
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING LOG REVIEW AND SPEAKING TO THE SITE, THE FOLLOWING IS KNOWN CONCERNING THE ISSUE: FF2P ERROR CODE FLAGGING AT (B)(6) 2025 09:37:29, WHICH IS SOMETIMES AN EBOX SYNC TRIGGER PROBLEM, AND HAS BEEN ASSOCIATED WITH LOCKUPS NOTED IN TRAC-SSI#125. WE DID RECEIVE THE EBOX LOGS FROM THE SITE AND CONCLUDED THAT THE SYSTEM LOCKUP IS MOST LIKELY THE SAME INTERMITTENT ISSUE WE HAVE SEEN IN THIS TICKET. SEPARATELY TO THE INTERNAL LOG REVIEW, AN ADDITIONAL SUCCESSFUL EXAM WITH THREE CLIPS (SAVED) WAS PERFORMED FOLLOWING RESTART.

    Description of Event or Problem · 0

    DURING A PATIENT SCAN AND AFTER SAVING THE FIRST CLIP, THE SYSTEM BECAME COMPLETELY UNRESPONSIVE, I.E. NONE OF THE TOUCH TABS OR BUTTONS WERE FUNCTIONAL. AS A RESULT, SITE UNABLE TO PROCEED WITH THE SCAN AND HAD TO SHUT DOWN THE SYSTEM IN ORDER TO PREPARE IT FOR THE NEXT PATIENT. THIS WAS UNDERSTANDABLY DISTRESSING FOR THE PATIENT UNDERGOING BIOPSY AND QUITE CHALLENGING FOR OUR TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437106 IMAGIO BREAST IMAGING SYSTEM, MODEL 9100 IMAGING SYSTEM QNK SENO MEDICAL, INC. 9100 N/A 00864802000459

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown