BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORTEC

    MDR report key: 2946168 · Received January 29, 2013

    Report

    Report Number
    2946168
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 29, 2013
    Manufacturer
    SANDHILL SCIENTIFIC
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PH PROBE WAS PLACED WHILE PATIENT WAS IN SURGERY. X-RAY WAS DONE AND SHOWED PROBE WAS CURLED. PROBE WAS PULLED OUT SOME AND REPLACED, PER THE PHYSICIAN'S RECOMMENDATION. X-RAY DONE AND SENSOR PART OF PROBE CORRECT, BUT 'TAIL' CURLED. PROBE REMOVED AND REPLACED, X-RAY DONE, AND WAS PROBE WAS CURLED AGAIN. THIS OCCURRED A TOTAL OF THREE TIMES. NEW PROBE PLACED, X-RAY DONE AND IN CORRECT SPOT AND NOT CURLED. EACH TUBE THAT WAS PULLED OUT WAS CURLED AND WOULD NOT UNCURL. THE DEVICE WERE NOT CURLED WHEN REMOVED FROM THE PACKAGING. THIS IS THE FIRST INSTANCE WHERE STAFF HAVE ENCOUNTERED THIS PROBLEM WITH THIS DEVICE. IN THIS CASE, THERE WERE A TOTAL OF THREE ATTEMPTS MADE IN A ROW WITH THE SAME DEVICE, SAME LOT NUMBER AND THE SAME ISSUES. NO PATIENT HARM. PATIENT TOLERATED PROCEDURE WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38461 COMFORTEC ELECTRODE, PH, STOMACH FFT SANDHILL SCIENTIFIC * *
    38532 COMFORTEC ELECTRODE, PH, STOMACH FFT SANDHILL SCIENTIFIC * *
    38533 COMFORTEC ELECTRODE, PH, STOMACH FFT SANDHILL SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR