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 Superficial (First Degree) Burn (2685)

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.There was no report of medical intervention associated with the development of a blister after the nurse touched the tip of the thermometer.This evaluation addresses the event involving the nurse.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.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.For the purposes of this evaluation, a burn resulting in a blister is categorized as a second-degree burn.This type of burn injures the top layer of skin (epidermis) as well as the tissue below the skin (dermis).Second-degree burns may be characterized by the development of blisters, red, splotchy appearance of the skin and pain can be severe.Second-degree burns limited to an area no larger than 3 inches (7.6 centimeters) in diameter are considered minor and are treated as such.These minor burns will usually heal without further treatment and do not require treatment to prevent a permanent impairment of a body function or structure and are not considered a serious injury.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.There was no report of medical intervention associated with the development of a blister after the nurse touched the tip of the thermometer.This evaluation addresses the event involving the nurse.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: 12859811
• MDR Text Key: 288614110
• Report Number: 1316463-2021-00072
• 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

• Date FDA Received: 11/23/2021
• 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
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1