BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2203818 · Received August 11, 2011

    Report

    Report Number
    3004593495-2011-00063
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD.
    Product Code
    DPS
    PMA / PMN Number
    P890003/S154
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT FOLLOWING STORMS IN THE AREA THE CARELINK MONITOR WAS NOT RECEIVING ELECTRICAL POWER. A NEW POWER CORD WAS SENT OUT. IT WAS FURTHER REPORTED THAT THE NEW POWER CORD DID GET POWER TO THE MONITOR, BUT WHEN THE MONITOR IS CONNECTED INTO THE PHONE JACK THE HOME PHONES WILL NOT WORK. THE MONITOR IS BEING REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PATIENT MONITORING INSTRUMENT DPS PLEXUS MANUFACTURING SDN. BHD. 2490C8 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 0125 COMPETITOR IMPLANTABLE TACHY LEAD