The customer reported that the probe tip of their braun pro6000 overheated and burned the patients ear.The severity of the burn and medical intervention, if any, was not reported by the customer.Multiple attempts to obtain additional details of the event have been unsuccessful.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.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 devices 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.The customer did not provide the necessary information to determine the severity of harm for the report of burn to the patient's ear canal.If additional relevant information is reported, the injury will be characterized accordingly.However, 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 serious injury we have deemed this complaint to be reportable.
|
The customer reported the pro 6000 ear thermometer burned a patient during use.The customer did not provide the severity of the burn and medical intervention, if any, was not reported.Multiple attempts to obtain additional details of the event have been unsuccessful.This report was filed in our complaint handling system as complaint #(b)(4).
|