BEUDAMED
    FDA Adverse Event Summary report: N

    T/PUMP HEAT THERAPY SYSTEM

    MDR report key: 1274504 · Received December 31, 2008

    Report

    Report Number
    1274504
    Date Received
    December 31, 2008
    Date of Event
    November 6, 2008
    Report Date
    December 31, 2008
    Manufacturer
    GAYMAR INDUSTRIES, INC
    Product Code
    ILO
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELDERLY PATIENT ADMITTED TO PALLIATIVE CARE SERVICE FOR SUPPORTIVE CARE. A GAYMAR T/PUMP HEAT THERAPY SYSTEM AND SINGLE PAD WAS INITIATED ON ADMISSION PER ROUTINE PHYSICIAN ORDER FOR PATIENT'S COMPLAINT OF BACK PAIN/DISCOMFORT. FOUR DAYS LATER, WHILE A NURSE AND AN AIDE WERE GIVING THE PATIENT A BATH, THE NURSE NOTED A HONEYCOMB PATTERN AND BURNS ON THE PATIENT'S BACK. THE NURSE THAT CARED FOR THE PATIENT THE DAY PRIOR INDICATED THAT THE PATIENT DID NOT HAVE THESE MARKS YESTERDAY AT BATH TIME (A.M.). A NURSE PRACTITIONER EVALUATED THE PATIENT AND REPORTED A THIRD DEGREE BURN TO RIGHT FLANK AND BACK. THERE WAS NO DRAINAGE. THE BURN WAS FROM THE T/PAD HEAT THERAPY. THE GAYMAR HEATING SYSTEM WAS REMOVED FROM SERVICE AND WAS NOT REPLACED WITH ANOTHER. SILVADENE CREAM WAS ORDERED TO BE APPLIED TWICE A DAY ALONG WITH GAUZE DRESSING UNTIL THE BURN IS HEALED. PATIENT'S BURN CARE ORDERED TO BE CONTINUED AT DISCHARGE TO NURSING HOME ONE WEEK LATER.BIOMEDICAL ENGINEERING INSPECTED THE UNIT USING THE GAYMAR TEST FIXTURE AND CALIBRATION EQUIPMENT ALONG WITH A DIGITAL THERMOMETER. THE FOLLOWING READINGS WERE TAKEN:PRIMARY T-STAT CUT OUT AT 105.1 DEGREES (FACTORY SPEC 105 + OR - 2 DEGREES).MANIFOLD T-STAT CUT OUT AT 114 DEGREES (FACTORY SPEC 111 TO 117 DEGREES). WELL T-STAT CUT OUT AT 116 DEGREES (FACTORY SPEC 110-122 DEGREES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T/PUMP HEAT THERAPY SYSTEM PACK, HOT OR COLD, WATER CIRCULATING ILO GAYMAR INDUSTRIES, INC TP500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR