BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2831343 · Received November 14, 2012

    Report

    Report Number
    1226420-2012-00061
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. RESULTS: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. CONCLUSION: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. PRODUCT EVENT: (B)(4).

    Description of Event or Problem · 1

    COAG MODE DOES NOT FUNCTION.

    Description of Event or Problem · 1

    COAG MODE DOES NOT WORK BUT IT DOES CUT FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR II GENERATOR GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1