The criticool has been returned to belmont for investigation; evaluation of the unit is in process.The user facility reported that while the criticool was in use, the patient was noted to be warmer than the set temperature and the device was not alarming.The alarm for a patient's high temperature can be configured in "settings"; the user can select from the following available values: 36°c, 36.5°c, 37°c, 37.5°c, 38°c, 38.5°c, and the alarm and message are issued according to the selected alarm limit.The operator's manual also provides recommended corrective actions in the event that the patient's temperature is above the set point.Without results of the investigation a root cause of the reported problem cannot be established.The user facility also reported that the criticool subsequently began exhibiting a "halt 4" alarm after it had been removed from use.The criticool is equipped with self-testing routines that continuously monitor system operation and displays a fault message in the event of a system fault.The unit exhibits a "halt 4" alarm when a flow problem is detected during self-test.In the event of a halt 4 alarm, the system disables by turning off the pump and displays an alarm message with instructions for corrective measure.The manufacturing and service records for this serial number were reviewed and no anomalies were identified.There was no patient injury reported.A supplemental report will be submitted upon completion of the investigation.
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