The customer reported that the probe tip of their braun pro6000 overheated and the device does not perform temperature readings.There were no allegations of injury.The braun/welch allyn thermoscan pro 6000 ear thermometer is indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment.The probe cover is used as a sanitary barrier between the infrared thermometer and the ear canal.To help ensure accurate temperature measurements, the sensor itself is warmed to a temperature close to that of the human body.When the braun/welch allyn thermoscan is placed in the ear, it continuously monitors the infrared energy until a temperature equilibrium has been reached and an accurate measurement can be taken.Temperature regulation is part of a normal homeostasis where the body attempts to maintain an optimal body temperature.Temperature varies person to person secondary to both individual physiological factors, and environmental influences.Temperature is routinely obtained during routine physical assessment and is considered one part of a set of vital signs (blood pressure, pulse and respirations).Temperature can be assessed numerically through use of a thermometry device or also through patient presentation (patient verbalizations of coldness or hotness, presence or absence of shivering or sweating, skin color, and skin temperature to touch).If the thermometer is unavailable for use, this will be readily detected by the user/clinician.A clinician would immediately recognize the device is not working and would remove it from clinical service until the device was either repaired or replaced.If the device was unavailable for use, the clinician would likely obtain an alternative device.For this reason, we do not consider a device that is unavailable for use, a reportable incident.Hillrom/welch allyn¿s investigation of pro 6000 ¿hot tip¿ complaints confirmed that aggressive cleaning and decontamination practices can cause liquid ingress.Consequently, liquid ingress can adversely affect the temperature sensor causing the pro 6000 device to behave inconsistently and to overheat the speculum tip.It is believed that replication of the malfunction with the returned device from the customer at the manufacturing site has not been possible as any fluid that may have ingressed had likely evaporated, therefore not showing the ¿hot tip¿ malfunction.Based on hillrom¿s ability to replicate the malfunction of a ¿hot tip¿ on new devices that can potentially go above the built in risk mitigations of a safety cut off that could potentially cause a more serious injury we have deemed this complaint to be reportable for the "hot probe tip" malfunction.
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