BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2856305 · Received December 4, 2012

    Report

    Report Number
    1226420-2012-00086
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 7, 2012
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC,
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) LHR / DHR REVIEW: NO ASSOCIATED MANUFACTURING OR SERVICING ISSUES (NO PREVIOUS RETURNS) EVALUATION PROCESS AND OUTCOME: COLD SOLDER JOINTS ON THE COMPONENT R7 AMP BOARD PREVENTED CURRENT FROM BEING RELIABLY DELIVERED TO OUTPUT TRANSFORMER T3, YIELDING REDUCED POWER OUTPUT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. RESULTS: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. PRODUCT EVENT: (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.

    Description of Event or Problem · 1

    DEVICE STOPPED WORKING DURING CASE.

    Description of Event or Problem · 1

    DEVICE STOPPED WORKING DURING CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1