BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3992879 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02360
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE PRINTER WAS UNABLE TO PRINT AND OUT OF PAPER MESSAGE DISPLAYED; PRINTER FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE PRINTER DRAWER RELEASE MECHANISM AND THE KEYBOARD HINGES ARE BROKEN. TIP OF STYLUS PEN IS VERY LOOSE. ECG (ELECTROCARDIOGRAM) CONNECTOR ON A PCB (PRINTED CIRCUIT BOARD) ASSEMBLY WAS FOUND LOOSE AND THIS PCB ASSEMBLY FAILED FUNCTIONAL TESTS; THE PCB ASSEMBLY FOUND OUT OF ELECTRICAL SPECIFICATION. LOWER CASE DOES NOT LINE UP WITH UPPER CASE CAUSING IT NOT TO CLOSE PROPERLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER PRINTER WILL NOT PRINT. IT IS NOTED A FULL SIZE PRINTER DOES WORK. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468034 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 229047 ANALYZER