BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM SMART OCCLUDER

    MDR report key: 21264089 · Received January 29, 2025

    Report

    Report Number
    3006073153-2025-00015
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    September 19, 2022
    Report Date
    January 29, 2025
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTQ
    UDI-DI
    05060434421944
    PMA / PMN Number
    K190282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM LOGS WERE REVIEWED. SPECTRUM MEDICAL HAS IMPROVED IN THE LATEST OCCLUDER SW BUILD THE OCCLUSION PROFILE, WHICH IMPROVES FULL OCCLUSION AND ELIMINATES THE POTENTIAL FOR THE OCCLUDER TO RELAX DURING THE LATE STAGE OF CLOSING. THE LATEST OCCLUDER SW BUILD LOADED ON THE NETWORK. ACCOUNT REP CONFIRMED THAT NO ISSUES HAVE OCCURRED SINCE THE UPDATE TO OCCLUDERS.

    Description of Event or Problem · 0

    LOANER OCCLUDER THAT WAS SENT IN RESPONSE TO FON #(B)(6) STOPPED RESPONDING TO OPEN/CLOSE COMMANDS FROM THE QWS. REPORTEES ARE UNSURE IF THERE WAS A "NO OCCLUDER LOCATION" MESSAGE AT THE TIME OF THIS EVENT. THE OCCLUDER WAS ALSO REPORTED TO "EVENTUALLY START WORKING" AGAIN. ISSUE OCCURED APPROX. 1000 PRIOR TO A CASE. RECOMMENDATION WAS GIVEN TO TRY A NEW CABLE AND THEN A NEW PORT ON THE FRAME IF THE CABLE WAS DAMAGED FROM THE FRAME. NO FURTHER INFORMATION. SAME REP CONTACTED AGAIN AROUND 1700 STATING AS BIOMED ATTEMPTED TO DOWNLOAD LOGS FOR THE ISSUE ABOVE, ONLY THE QWS WOULD BOOT UP AND NOT THE REST OF THE SUBMODULES. REST OF THE PUMP WAS TURNED ON VIA THE SOLARIS POWER BUTTON BUT PUMP MANAGER WAS NOT PRESENT. SAP CABLE WAS UNPLUGGED FROM THE QWS AND REPLUGGED IN BUT PUMP MANAGER WAS STILL NOT PRESENT. QWS WAS THEN TURNED OFF WITH A LONG PRESS, THEN SAP CABLE UNPLUGGED AGAIN AND REPLUGGED IN. UPON BOOT UP PUMP MANAGER CAME BACK. MEDTRONIC REP WAS ON FACETIME WITH BIOMED AND VERIFIES THAT SOLARIS WAS PLUGGED INTO THE WALL DURING THIS TIME. HE ALSO SENT A PICTURE OF A QWS WITH A GREEN POWER LED IN THE BOTTOM RIGHT INSTEAD OF BLINKING BLUE, SUGGESTING THAT THE HLM WAS PLUGGED INTO THE WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792673 QUANTUM SMART OCCLUDER TUBE CLAMP DTQ SPECTRUM MEDICAL LTD QSOR 05060434421944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown