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 08/22/2023

Event Type  malfunction  

Event Description

The customer reported the pro 6000 probe tip burned a patient¿s ear causing a feeling of heat and visible redness to the inside of the ear.No medical intervention was provided.This incident was captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

The customer reported the pro 6000 probe tip burned a patient¿s ear causing a feeling of heat and visible redness to the inside of the ear.No medical intervention was provided.The thermoscan pro 6000 ear thermometer is indicated for the intermittent measurement of human body temperature.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.The report of a hot feeling or discomfort in the patient¿s ear is an unpleasant sensation occurring in varying degrees of severity and typically stops once the stimulus is removed.For the purposes of this evaluation, a burn resulting in redness of the skin is categorized as a first-degree burn.First degree burns injure the top layer of skin (epidermis) and cause the tissue below the skin (dermis) to become red and swollen.These minor burns will usually heal without further treatment.The patient in this event did not require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, concluding a serious injury did not occur.If the reported problem of a hot probe tip were to recur, it would be likely to cause or contribute to a death or serious injury.Hillrom is reporting this event.

• Brand Name: PRO 6000 W/SMALL CRADLE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street east; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17628851
• MDR Text Key: 322038294
• Report Number: 1316463-2023-00194
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00732094309003
• UDI-Public: 732094309003
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2023

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: 08/23/2023
• Initial Date FDA Received: 08/26/2023
• 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