The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be a defective temperature cable.However, this cannot be confirmed.The biomed checked the cable and it was frayed.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿temperature probe placement patient temperature control with the arctic sun® temperature management system requires patient temperature feedback provided by an indwelling patient temperature probe connected to the patient temperature 1 connector on the back of the control module.Any commercially-available yellow springs instrument 400 series (ysi 400) compatible patient temperature probe can be connected to the arctic sun® temperature management system.Refer to the manufacturer¿s instructions for use for the specific indications and temperature probe placement." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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