BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GB A-V IMPULSE SYSTEM 6000

    MDR report key: 5245867 · Received November 24, 2015

    Report

    Report Number
    1282497-2015-00070
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 9, 2015
    Manufacturer
    NOVAMEDIX
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 11/24/2015. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, A FULL DETAILED INVESTIGATION WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION DATE: 02/17/2016 AN INVESTIGATION OF AV IMPULSE SYSTEM FOR THE REPORTED CONDITION WAS PERFORMED. A REVIEW OF THE INFORMATION IN THE COMPLAINT FILE INDICATES THIS INVESTIGATION WAS PERFORMED BY A MEDTRONIC TECHNICAL CENTER FOR THE REPORTED CONDITION OF; POWER CORD¿ LIVE PIN IS BROKEN OFF. THEREFORE, THIS REPORT WILL BE BASED ON INFORMATION PROVIDED BY THE TECHNICAL CENTER. THE UNIT WAS TRIAGED AND THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE REPORTED CAN BE ATTRIBUTED TO ROUGH HANDLING OF THE UNIT. POWER CORDS PERIODICALLY REQUIRE REPLACEMENT DUE TO AGE, USAGE AND USER DAMAGE. THE SERVICE MANUAL INSTRUCTS THE USER TO PERIODICALLY INSPECT THE POWER CORDS RESISTANCE TO ENSURE ITS ELECTRICAL SAFETY. THE UNIT WAS SCRAPPED AND REPLACED TO CORRECT THE PROBLEM. ALL DEVICE HISTORY RECORDS ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT THE CUSTOMER INITIATED A SERVICE REPAIR REQUEST REGARDING AN AV IMPULSE SYSTEM. THE UNIT WAS RETURNED TO A LOCAL COVIDIEN TECHNICAL CENTER AND UPON TRIAGE FOUND A LIVE PIN HAD BEEN BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776391 GB A-V IMPULSE SYSTEM 6000 A-V IMPULSE SYSTEM MHY NOVAMEDIX AV6000-UK

    Patients

    Seq Age Sex Outcome Treatment
    1