BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PS100-100 PULSAR

    MDR report key: 2915653 · Received January 15, 2013

    Report

    Report Number
    1226420-2013-00015
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 15, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    DURING A CASE, COAG FUNCTION FAILED TO WORK ON GENERATOR. UPON REBOOTING GENERATOR AND REPLACING DEVICE, THE CASE CONTINUED AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22088 GENERATOR PS100-100 PULSAR GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-100

    Patients

    Seq Age Sex Outcome Treatment
    1