BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFG-3CF SYSTEM, 117 V/60 HZ

    MDR report key: 1165685 · Received September 15, 2008

    Report

    Report Number
    1717344-2008-00397
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    NBN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE GROUNDING PAD WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORT STATED THAT AT THE BEGINNING OF THE PAIN MGMT PROCEDURE, THE TEMP ON THE GENERATOR WOULD NOT GO PAST 35. THE MACHINE WAS TURNED OFF AND BACK ON THE TEMP WOULD NOT GO PAST 40. THE GENERATOR WAS UNPLUGGED AND TURNED BACK ON AND A DIFFERENT PROBE AND PAD WERE USED BUT THE TEMP STILL WOULD NOT GET ABOVE 40. THE PROCEDURE WAS STOPPED. AFTER THE PROCEDURE, STAFF FOUND THAT THE PT HAD RED, RASH-LIKE MARKS WHERE THE PAD HAD BEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RFG-3CF SYSTEM, 117 V/60 HZ PAIN MANAGEMENT GENERATOR NBN COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT# IN3664| COVIDIEN PAIN MANAGEMEN GROUNDING PAD