BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIONICS

    MDR report key: 283869 · Received June 23, 2000

    Report

    Report Number
    283869
    Event Type
    Malfunction
    Date Received
    June 23, 2000
    Date of Event
    June 16, 2000
    Report Date
    June 22, 2000
    Manufacturer
    OMNI MEDICAL
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RADIONICS RADIOFREQUENCY MACHINE MODEL RFG-3C GRAPHICS RF LESION GENERATOR SYSTEM. USED FOR RF PROCEDURE, CERVICAL. DEMONSTRATED ACCURATE SELF CHECK PRIOR TO PROCEDURE. PERFORMED 1ST LEVEL WITHOUT INCIDENT. 2ND LEVEL MACHINE GUAGES REGISTERED INAPPROPRIATE READING AT A FAST, IRREGULAR RATE. PROCEDURE ABORTED. SUBSEQUENT CASES CANCELED. THE DEVICE IS BEING SENT OUT FOR INSPECTION BUT WILL BE AVAILABLE TO MFR AT A LATER DATE FOR EVAL AND REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIONICS RADIOFREQUENCY MACHINE GXD OMNI MEDICAL RFG-3C 0

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other