BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 2860103 · Received November 21, 2012

    Report

    Report Number
    2242352-2012-01241
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K043155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE T.W. POWER SUPPLY LED ON/OFF LIGHT ON THE TOP OF THE GENERATOR WAS OPERATING INTERMITTENTLY. THE HOSPITAL REPORTED THAT THERE WAS NO PT INVOLVEMENT; THEREFORE, THERE WERE NO PT EFFECTS. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T.W. POWER SUPPLY ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA