Stryker—Gaymar Medi-Therm Hyper/Hypothermia Units: Water Temperature Display May Be Blank in Auto Mode

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In a December 27, 2013, Urgent Medical Device Notification letter submitted by ECRI Institute member hospitals, Stryker states that the water temperature display on some of the hyper/hypothermia units below may be blank in automatic mode. If the user wants to see the water temperature displayed and switches out of automatic mode to manual mode and back again, the therapy will be reset, potentially resulting in patients reaching the set temperature point earlier than anticipated. Stryker states that the rate of controlled rewarming is a set slope controlled by the units below. If switched out of auto mode, the patient's passive rewarming is no longer controlled by the unit and when switched back into auto mode, the unit will use the patient's temperature as the new starting temperature. The unit will resume control of the rate of warming; however, the patient's temperature may have been raised to a higher point while in manual mode because of the patient's passive rewarming ability. Stryker further states that the probability of harm requiring medical intervention is high for at-risk populations, including patients undergoing therapeutic hypothermia who are being rewarmed. The manufacturer has not confirmed the...