Photographs provided by the user facility indicate red marks on the patient's back and knee, however it is unclear whether these are the result of burns, bruising, or another type of skin damage.At the time of the incident, the reporting department at the user facility was in possession of two belmont-owned demo/loaner criticool devices but was unable to determine which of the two serial numbers was involved.The criticools were returned to belmont at the end of the hospital's trial evaluation and were tested according to our standard operating procedures.Both units performed according to our specifications upon receipt.The nurse educator reported that the patient is in liver failure and on vasopressors; it was noted that these patients tend to have fragile skin.The department has reportedly used the criticools on several other patients without issue.Further follow up revealed that the wound nurse was unable to determine whether the reported markings on the patient were the result of pressure or burn, furthermore the nurse educator confirmed that the patients in the department (transplant icu) do have compromised skin.The manufacturing records for both serial numbers were reviewed and no anomalies were identified.A review of past complaints indicates that this is an isolated incident, no trend has been identified for this type of issue.Should additional information become available, a supplemental report will be provided.
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