BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2864897 · Received December 10, 2012

    Report

    Report Number
    2182208-2012-04058
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    October 2, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE DISPLAY SCREEN WAS FAINT. IT WAS ALSO NOTED THAT THE POWER CORD DOOR WAS MISSING, THE SYSTEM FAN WAS NOISY, THE STYLUS WAS MISSING AND THERE WAS LIMITED WIRELESS INTERROGATION DUE TO THE RADIOFREQUENCY TRANSCEIVER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREEN BULB WAS NOT WORKING. THE PROGRAMMER WAS RETURNED 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
    1 CARELINK PROGRAMMER, PACEMAKER KRG RICE CREEK MFG 2090AM

    Patients

    Seq Age Sex Outcome Treatment
    1