BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GB A-V IMPULSE SYSTEM 6000

    MDR report key: 5680042 · Received May 25, 2016

    Report

    Report Number
    1282497-2016-00259
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Report Date
    May 4, 2016
    Manufacturer
    COVIDIEN
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 05/25/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, A FULL REPORT SHALL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 08/25/2016. AN INVESTIGATION OF AV IMPULSE WAS PERFORMED FOR THE REPORTED CONDITION OF A BURNT CONTACT ON THE UNIT¿S MAIN POWER SWITCH. THE UNIT WAS TRIAGED AND THE COMPLAINT WAS CONFIRMED; NO BLOWN FUSES OR EVIDENCE OF ¿OVERCURRENT¿ CONDITIONS WERE OBSERVED OR NOTED. THE UNIT¿S MAIN POWER SWITCH WAS REPLACED TO CORRECT THE ISSUE. THE UNIT WAS TESTED; UNIT PASSED ALL TESTING. AT THE TIME OF MANUFACTURING, THE DEVICE WAS RELEASED MEETING ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN AVI UNIT. UPON TRIAGE ON (B)(6) 2016, THE SERVICE TECHNICIAN FOUND THAT THE UNIT'S MAINS POWER SWITCH CONTACT WAS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332776 GB A-V IMPULSE SYSTEM 6000 AVI CONTROLLER MHY COVIDIEN AV6000-UK

    Patients

    Seq Age Sex Outcome Treatment
    1