Catalog Number 8001000001 |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2024 |
Event Type
malfunction
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Event Description
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It was reported that the temperature deviation alarm was occurring due to the patient temperature being more than 0.5 degrees from target temperature.It was reported that the device was in auto mode, with a rectal temperature of 35.4 and is correlating to a secondary temperature.The wraps are cool to the touch and the water temperature is 40 degrees.It was reported that they were originally cooling the patient and met the target temperature and now were re-warming however, the patient was not warming to the goal as fast as expected.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
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Event Description
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It was reported that the temperature deviation alarm was occurring due to the patient temperature being more than 0.5 degrees from target temperature.It was reported that the device was in auto mode, with a rectal temperature of 35.4 and is correlating to a secondary temperature.The wraps are cool to the touch and the water temperature is 40 degrees.It was reported that they were originally cooling the patient and met the target temperature and now were re-warming however, the patient was not warming to the goal as fast as expected.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
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Manufacturer Narrative
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Information provided by the user facility identified that the device was rewarming the patient to counteract an underlying patient condition, which resulted in the patient's temperature dropping.Based on this information,it was determined that the temperature deviation alarm was likely not due to any component level malfunction and instead due to the patient's underlying condition.This issue was resolved for the customer by ensuring that the device was functioning correctly and recommending the nurse confer with the providers regarding the patient's condition.The manufacturing date section h4 and the h6 codes have been corrected.
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Search Alerts/Recalls
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