MAUDE Adverse Event Report: WELCH ALLYN INC. PRO 6000 W/SMALL CRADLE; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 06000-200

Device Problem Excessive Heating (4030)

Patient Problem Burning Sensation (2146)

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that during use with the pro 6000 ear thermometer, the patient complained of a burning feeling in their ear and the device was immediately taken out of the patient's ear.The nurse checked the probe tip, and the nurse felt the tip was very hot and had a small blister due to the heat.No serious outcome or medical intervention was reported in association with the burning feeling experienced by the patient.This evaluation addresses the event involving the patient.The 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 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 report of a burning feeling/discomfort in the patient¿s ear is an unpleasant sensation occurring in varying degrees of severity and typically stops once the stimulus is removed.There was no information provided by the customer to characterize if the burning feeling the patient experienced led to skin damage.Pain or discomfort is not life threatening and does not require treatment to prevent a permanent impairment of a body function or structure and is not considered a serious injury.The customer report of the patient experiencing a burning feeling in the ear is not reportable.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.

Event Description

The customer reported that during use with the pro 6000 ear thermometer, the patient complained of a burning feeling in their ear and the device was immediately taken out of the patient's ear.The nurse checked the probe tip, and the nurse felt the tip was very hot and had a small blister due to the heat.No serious outcome or medical intervention was reported in association with the burning feeling experienced by the patient.This evaluation addresses the event involving the patient.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: PRO 6000 W/SMALL CRADLE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 12859880
• MDR Text Key: 284193067
• Report Number: 1316463-2021-00073
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00732094309003
• UDI-Public: 732094309003
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 06000-200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1