BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2952253 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00150
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE ELECTROCARDIOGRAM (ECG) CONNECTOR AND HANDLE UPDATE WAS REQUIRED, NO STYLUS WAS PRESENT. THE REPORTED EVENT COULD NOT BE CONFIRMED, BUT SOFTWARE WAS UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR MESSAGE DURING START UP. ANOTHER PROGRAMMER WAS USED. THE PROGRAMMER WILL BE RETURNED FOR SERVICE AND REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56244 CARELINK PROGRAMMER, PACEMAKER KRG RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR