BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152070 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01180
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. THE DISPLAY POWERED UP WITH PINK BACKGROUND DUE TO A LOOSE CONNECTION FROM THE LVDS (LOW VOLTAGE DIFFERENTIAL SIGNAL) BOARD TO THE DISPLAY. ANALYSIS ALSO FOUND THE SYSTEM FAN WAS NOISY. CONCOMITANT PRODUCTS: PRODUCT ID 229047 ANALYZER; PRODUCT ID 2067 RF (RADIO FREQUENCY) HEAD; PRODUCT ID 2067L RF HEAD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY SCREEN ON THE PROGRAMMER HAD LINES GOING ACROSS IT WHEN POWERED UP. THE PROGRAMMER IS BEING RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252894 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1