BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR 2 GENERATOR

    MDR report key: 2815551 · Received November 1, 2012

    Report

    Report Number
    1226420-2012-00046
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    September 28, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    INTERFERENCE WITH THE ANESTHESIA CART WHEN DEVICE ACTIVATED (PULSE O2 AND CARDIAC RHYTHM). ORIGINAL SETUP UTILIZED TO COMPLETE CASE, ANESTHESIOLOGIST FELT AS THOUGH PATIENT WAS NOT AT RISK AND PROCEDURE WAS SHORT.

    Description of Event or Problem · 1

    INTERFERENCE WITH THE ANESTHESIA CART WHEN DEVICE ACTIVATED (PULSE O2 AND CARDIAC RHYTHM). ORIGINAL SETUP UTILIZED TO COMPLETE CASE, ANESTHESIOLOGIST FELT AS THOUGH PATIENT WAS NOT AT RISK AND PROCEDURE WAS SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR 2 GENERATOR GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other