Company: Stryker Medical Division of Stryker Corporation
Date of Enforcement Report:2/122014
Class lI:
PRODUCT
The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device’s control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system. The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.
Recall Number Z-0933-2014
REASON
Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to Auto mode, the therapy will be reset, and may potentially cause patients to reach the set point earlier. The rate of controlled rewarming is a set slope controlled by the Medi-therm unit. There is a potential that the patients passive rate of rewarming is greater than the rate-controlled rewarming. If switched out of Auto mode, the patients passive rewarming is no longer controlled by the machine, which allows the patient to rewarm at their passive rate. Once switched back into Auto mode, the machine will use the patients current temperature as the new starting temperature. The Medi-therm unit will take back control of the rate of warming. However, the patients temperature may potentially have been raised to a higher point while outside of Auto mode due to the patients passive rewarming ability. Consequently, this may result in the patient reaching the target temperature earlier than if modes had not been..
RECALLING FIRM/MANUFACTURER
Stryker Medical Division of Stryker Corporationon, Portage, MI 12/27/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1002 units
DISTRIBUTION
Nationwide and Internationally
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