BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152103 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01173
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT OF NOISE ON THE ELECTROCARDIOGRAM (ECG) SCREEN, HOWEVER NO FAULT WAS FOUND WITH THE ECG AND NO ECG CABLES WERE RETURNED WITH THE PROGRAMMER. THE SCREEN WAS DISCOLORED WHICH MADE IT DIFFICULT TO READ THE SCREEN SO THE MICRO PROCESSING UNIT (MPU) PRINTED CIRCUIT BOARD (PCB) WAS REPLACED. THE HARD DISK DRIVE WAS ALSO REIMAGED AND THE CURRENT SOFTWARE RELOADED. THE PROGRAMMER PASSED ALL FUNCTIONAL SYSTEMS TESTING. CONCOMITANT PRODUCTS: PRODUCT ID 2067L RADIO FREQUENCY PROGRAMMER HEAD; PRODUCT ID 229047 SOFTWARE ANALYZER.(B)(4).

    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. CONCOMITANT PRODUCTS: PRODUCT ID 2067L RADIO FREQUENCY PROGRAMMER HEAD; 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD NOISE ON THE ELECTROCARDIOGRAM (EKG) SCREEN. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD NOISE ON THE ELECTROCARDIOGRAM (EKG) SCREEN. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252910 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1