BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRA HC LEGEND SERIES

    MDR report key: 598824 · Received April 28, 2005

    Report

    Report Number
    MW1035323
    Event Type
    Malfunction
    Date Received
    April 28, 2005
    Date of Event
    April 22, 2005
    Report Date
    April 28, 2005
    Manufacturer
    CHATTANOOGA GROUP INC
    Product Code
    IMG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ULTRASOUND TREATMENT - ON PT'S RIGHT SHOULDER USING 3.3 MHZ SOUND LEAD, 50% DUTY CYCLE AT 1.0 WCM2 X 10:00. TWO MINUTES INTO TREATMENT THE SOUND LEAD OVER HEATED & UNIT TURNED OFF, BUT NOT UNTIL OVERHEATING THE ANTERIOR ASPECT OF PT'S SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA HC LEGEND SERIES ELECTRICAL GENERATOR (2,12) IMG CHATTANOOGA GROUP INC 361228457 *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other