BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUDSON ADULT DUAL TEMPERATURE PROBE

    MDR report key: 843024 · Received April 20, 2007

    Report

    Report Number
    3003898360-2007-00023
    Event Type
    Other
    Date Received
    April 20, 2007
    Report Date
    March 23, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE IS ESSENTIALLY A VARIABLE RESISTANCE LOAD WITH A LOW VOLTAGE AND LOW CURRENT. THE MAXIMUM CURRENT IS 1.2 MA. IF A PERSON WERE ABLE TO TOUCH THE WIRES IN A PROBE, THE VOLTAGE AND CURRENT WOULD NOT BE ENOUGH TO SHOCK THEM. THE PROBE WIRES ARE ELECTRICALLY INSULATED. A VISUAL EXAMINATION, OF THE PROBE RECEIVED; FOUND A SMALL NICK IN THE MIDDLE OF THE PROBE LEAD INSULATION. HOWEVER, THE WIRES WERE NOT EXPOSED. ELECTRICAL TESTING DID DETECT AN INTERMITTENT OPEN AT THE NECK OF THE PROBE (STEREO PHONE SIDE). THE OPEN IS MOST LIKELY DUE TO CONTINUOUS USE AND/OR HANDLING DAMAGE. WHEN A PROBE HAS AN OPEN RESISTANCE, IT DOES NOT FUNCTION CORRECTLY AND WILL RESULT IN A CONCHATHERM HEATER ALARMING. A REVIEW FOUND THE PROBE WAS MANUFACTURED OVER SEVEN YEARS AGO.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 3/23/2007, THAT AN INCIDENT OCCURRED INVOLVING AN ADULT TEMPERATURE PROBE. A HOSPITAL STAFF REPORTEDLY RECEIVED A SHOCK FROM THE DEVICE. NO STAFF/PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ADULT DUAL TEMPERATURE PROBE TEMPERATURE PROBE FLL TELEFLEX MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other