It was reported that a patient allegedly experienced frostbite to his bilateral lower extremities during arctic sun therapy.
A physician placed a call to the ms&s helpline on (b)(6) 2019 at 2:23 pm to report that he had a patient with peripheral vascular disease on normothermia who developed frostbite.
He also stated that the patient was no longer on the device during the time of the call.
On (b)(6) 2019, it was reported via email from (b)(6), stating that the patient expired unrelated to the device.
The patient was placed on the arctic sun device on (b)(6) 2019 due to hyperthermia.
Skin assessments were performed every four hours on the patient.
On (b)(6) 2019, blisters and a mottled appearance were noted on the patient¿s thighs bilaterally and on the right knee, and mepilex dressings were applied to the affected areas.
The patient weighed (b)(6) and a set of large pads were in use.
The water temperature ranged from 4.
7c to 41.
9c during therapy.
The cause of death is unknown at this time; however, the facility stated that the patient expired unrelated to the device.
The patient was found unresponsive and admitted to the hospital with seizures, myocardial infarction, bacterial meningitis, sepsis, respiratory failure, positive posturing, rhabdomyolysis, and diabetic ketoacidosis.
The device was evaluated and passed the functional check and then returned to service.
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