BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2183613-2012-00515

    MDR report key: 2527107 · Received April 11, 2012

    Report

    Report Number
    2183613-2012-00515
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    January 10, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DPS
    PMA / PMN Number
    K024278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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) NO ANOMALIES 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.

    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 CLIENT THAT "NOTHING BUT NOISE" WAS SEEN WHEN TRYING TO RECORD IN-CLINIC ELECTROCARDIOGRAMS (ECGS). THE CLIENT ALSO REPORTED THAT THE COMPUTER THE ECG MODULE WAS CONNECTED TO "FRIED" WITH A "BURNING SMELL" WITH THE MODULE CONNECTED AND SITTING ON TOP OF IT. A NEW COMPUTER WAS INSTALLED AND THE ECG MODULE CONNECTED AND ONLY "NOISE" WAS SEEN. THE PATIENT CABLE AND LEADS ARE NEW AND THE UNIVERSAL SERIAL BUS (USB) CABLE WAS NEW AS WELL. NOISE-FILTERING AND OTHER SETTINGS WERE ALSO TRIED WITH NO SUCCESS. THE MODULE WILL BE REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLIENT THAT "NOTHING BUT NOISE" WAS SEEN WHEN TRYING TO RECORD IN-CLINIC ELECTROCARDIOGRAMS (ECGS). THE CLIENT ALSO REPORTED THAT THE COMPUTER THE ECG MODULE WAS CONNECTED TO "FRIED," WITH A "BURNING SMELL," WITH THE MODULE CONNECTED AND SITTING ON TOP OF IT. A NEW COMPUTER WAS INSTALLED, AND THE ECG MODULE CONNECTED, AND ONLY "NOISE" WAS SEEN. THE PATIENT CABLE AND LEADS WERE NEW, AND THE UNIVERSAL SERIAL BUS (USB) CABLE WAS NEW AS WELL. NOISE-FILTERING AND OTHER SETTINGS WERE ALSO TRIED, WITH NO SUCCESS. THE MODULE WAS RETURNED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DPS MEDTRONIC MILACA INC. P127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other