MAUDE Adverse Event Report: WELCH ALLYN INC. PRO6000 BULK PACK, WA; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 419712

Device Problem Excessive Heating (4030)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the metal tip on the pro 6000 thermometer was getting excessively hot and burned the user's (caregiver) ear.Specific details of the reported burn were not provided, however, the customer reported that no medical intervention was required.The customer reported that it is unknown if the device displayed any visual/audible messages prior to this use, however, during testing, the device did not overheat and displayed a ^i symbol.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.Instructions for use state always use a new disposable probe cover for each measurement.Burns are the result of tissue damage that is caused by exposure to heat, electricity, radiation, or sun exposure and are categorized as first-degree (minor, red/painful affecting only the outer layer of the skin) to third-degree (involves all three skin layers, destroys sweat glands/hair follicles) based on the severity of the burn.Treatment for a burn depends on the location and the severity of the damage.Minor first and second-degree burns typically do not require medical intervention and can be treated at home using aloe vera gel, over-the-counter antibiotic cream, and pain medication.It was reported that the user (caregiver) was burned and no medical intervention was required.For the purposes of this evaluation, this reported burn is categorized as a first-degree burn.This type of burn injures the top layer of the skin (epidermis).First-degree burns may be characterized as red and painful, are considered minor, and do not require medical intervention to preclude permanent impairment of a body structure or body function, which concludes a serious injury did not occur in this event.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.

Event Description

It was reported that the metal tip on the pro 6000 thermometer was getting excessively hot and burned the user's (caregiver) ear.Specific details of the reported burn were not provided, however, the customer reported that no medical intervention was required.This incident was captured under hillrom complaint ref # (b)(4).

• Brand Name: PRO6000 BULK PACK, WA
• 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: 17594482
• MDR Text Key: 321622107
• Report Number: 1316463-2023-00189
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/22/2023

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: 419712
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/22/2023
• 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