BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2848225 · Received November 28, 2012

    Report

    Report Number
    1226420-2012-00081
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 31, 2012
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC,
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT# (B)(4) EVALUATION PROCESS: UNIT RECEIVED IN POOR CONDITION AND UPON INTERNAL VISUAL INSPECTION THE LVPS HAD BROKEN LOOSE OF ITS MOUNTS AND WAS MOVING FREELY INSIDE THE RF MODULE. RF HIGH VOLTAGE HARNESS FOUND TO BE DISCONNECTED FROM HEADER J2 ON THE DC POWER PCBA. AFTER REMOUNTING AND RECONNECTING UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. ERROR LOG: 2 E11 (PATIENT RETURN ELECTRODE DISCONNECTED), 27 F9 (POWER SUPPLY UNDERCURRENT). E11 ARE NORMAL USE ERRORS AND F9 DUE TO DISCONNECTED RF HIGH VOLTAGE HARNESS. ROOT CAUSE: ROUGH HANDLING CAUSED THE LVPS TO BREAK FREE OF ITS MOUNTS AND THE RF HV HARNESS FREE FROM THE DC PCBA J2 CONNECTOR. (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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PULSAR II GENERATOR NOT PROPERLY WORKING. NO POWER TO DEVICE. GENERATOR WAS SWAPPED OUT AND DEVICE WORKED FINE.

    Description of Event or Problem · 1

    PULSAR II GENERATOR NOT PROPERLY WORKING. NO POWER TO DEVICE. GENERATOR WAS SWAPPED OUT AND DEVICE WORKED FINE.

    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