BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151776 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01258
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 5, 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

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT OF A LOUD FAN BUT COULD NOT CONFIRM ANY DISK DRIVE PROBLEMS. THE PROGRAMMER SAVED TO DISK WITHOUT ANY ISSUES. THE RF (RADIO-FREQUENCY) HEAD CONNECTOR ON THE PRINTED CIRCUIT BOARD WAS FOUND TO BE LOOSE, AND INTERROGATION WAS NOT POSSIBLE. THERE WAS ALSO A BROKEN TAB ON THE POWER CORD BAY DOOR, THE KEYBOARD LATCH WAS BROKEN, THE HARD DRIVE WAS OUT OF ELECTRICAL SPECIFICATION AND UNABLE TO BE RECONFIGURED, AND THE STYLUS WAS MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISK DRIVE DOES NOT WORK, AND THE FAN IS LOUD. THE PROGRAMMER WAS RETURNED FOR REPAIR. IT SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252434 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1