BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2131775 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00329
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S102
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MONITOR REACHED THE SEND PHASE, BUT THE BULLSEYE DID NOT LIGHT UP VERY BRIGHT. THEN, THE MONITOR WENT BACK TO THE BEGINNING AND SHUT OFF. DURING TROUBLESHOOTING ATTEMPTS, THE MONITOR DIALED OUT, BUT THE LIGHTS DID NOT PROGRESS, AND IT REDIALED AND BEEPED. THE PATIENT STATED THE WEATHER HAD BEEN BAD AND THOUGHT IT CAUSED A PROBLEM WITH THE MONITOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PATIENT MONITORING INSTRUMENT NVZ MEDTRONIC MILACA INC. 2490C ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PHONECORD PATIENT MONITORING ACCESSORY| POWER CORD PATIENT MONITORING ACCESSORY| POWER CORD PATIENT MONITORING ACCESSORY| PHONECORD PATIENT MONITORING ACCESSORY