BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791652 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03533
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 17, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE ANALYZER IS FUNCTIONING AND PASSES ALL FUNCTIONAL TESTING. HOWEVER, THE ANALYZER WAS NOT CONNECTING TO THE PROGRAMMER SO THAT IT CAN INITIALIZE. IT WOULD INITIALIZE ONLY WHEN THE ANALYZER SCREW WAS TIGHTENED INTO THE PROGRAMMER. A WHITE SCREEN WAS DISPLAYED JUST AS WAS REPORTED, BUT THIS WENT AWAY AFTER AN INFO DISK WAS RUN. IT WAS ALSO NOTED THAT THE LOWER CASE WAS SCRATCHED, THE LARGE HINGE PLATE BULLET COVER WAS MISSING AND THE OTHER LARGE BULLET COVER WAS DAMAGED, NO STYLUS PEN CAME WITH THE PROGRAMMER AND THE DISPLAY SCREEN DROPPED DOWN WHEN PLACED IN AN UPRIGHT POSITION. ADDITIONAL ANALYSIS WAS DONE ON THE ANALYZER. THIS ANALYSIS NOTED SOLDER FRACTURES PRESENT ON THE PRINTED CIRCUIT BOARD ASSEMBLY. AFTER THE SOLDER JOINTS WERE REFLOWED THE DEVICE PASSED FUNCTIONAL TESTING. THE FAILURE MODE WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE ANALYZER IS FUNCTIONING AND PASSES ALL FUNCTIONAL TESTING. HOWEVER, THE ANALYZER WAS NOT CONNECTING TO THE PROGRAMMER SO THAT IT CAN INITIALIZE. IT WOULD INITIALIZE ONLY WHEN THE ANALYZER SCREW WAS TIGHTENED INTO THE PROGRAMMER. A WHITE SCREEN WAS DISPLAYED JUST AS WAS REPORTED, BUT THIS WENT AWAY AFTER AN INFO DISK WAS RUN. IT WAS ALSO NOTED THAT THE LOWER CASE WAS SCRATCHED, THE LARGE HINGE PLATE BULLET COVER WAS MISSING AND THE OTHER LARGE BULLET COVER WAS DAMAGED, NO STYLUS PEN CAME WITH THE PROGRAMMER AND THE DISPLAY SCREEN DROPPED DOWN WHEN PLACED IN AN UPRIGHT POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DID NOT CONNECT WITH THE ANALYZER. MULTIPLE ANALYZERS WERE TRIED BUT THE SCREEN STAYED WHITE.THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS FURTHER NOTED THAT THE "BROKEN" ANALYZER WHICH WAS ALSO INCLUDED, HAD A BLANK SCREEN WHEN THE PROGRAMMER WAS SWITCHED OVER TO "ANALYZER" MODE. WHEN THE ANALYZER WAS CHANGED OUT, THE PROGRAMMER FUNCTIONED FINE IN "ANALYZER" MODE SO THIS ANALYZER WAS RETURNED. FOLLOW-UP INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DID NOT CONNECT WITH THE ANALYZER. MULTIPLE ANALYZERS WERE TRIED BUT THE SCREEN STAYED WHITE. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS FURTHER NOTED THAT THE "BROKEN" ANALYZER WHICH WAS ALSO INCLUDED, HAD A BLANK SCREEN WHEN THE PROGRAMMER WAS SWITCHED OVER TO "ANALYZER" MODE. WHEN THE ANALYZER WAS CHANGED OUT, THE PROGRAMMER FUNCTIONED FINE IN "ANALYZER" MODE SO THIS ANALYZER WAS RETURNED. FOLLOW-UP INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2290

    Patients

    Seq Age Sex Outcome Treatment
    1 Other