A follow-up report will be submitted upon completion of the investigation.At this time, there is indication of user error.The application site is too large or becomes too large due to edema, excessive pressure may be applied.This can result in venous congestion distal from the application site, leading to hypoxemia and tissue malnutrition.Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long.
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The investigation could not definitively confirm whether the device caused or contributed to the reported adverse event.Additional information was requested regarding the reported incident, but no response was received.Additionally, a return materials authorization (rma) form was sent for return of the product to philips.However, no material has been received for evaluation.The product¿s ifu states that, at elevated ambient temperatures, ¿patient skin could be severely burned after prolonged sensor application at sites that are not well perfused¿.The ifu instructs the user to check patient application sites frequently to prevent this condition.The ifu further describes that the sensors operate without risk of exceeding 41° c on the skin if the initial skin temperature does not exceed 35° c.Due to lack of response to requested additional information, it cannot be confirmed that this scenario occurred.As a result, we are considering this a malfunction of unknown cause.
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