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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN INC. PRO 6000 W/SMALL CRADLE; THERMOMETER, ELECTRONIC, CLINICAL
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WELCH ALLYN INC. PRO 6000 W/SMALL CRADLE; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Model Number 06000-200
Device Problem Excessive Heating (4030)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 07/27/2023
Event Type  malfunction  
Event Description
It was reported that the metal tip on the pro 6000 thermometer was getting excessively hot and burnt a patient¿s ear.Specific details of the reported burn were not provided, however, the customer reported that no medical intervention was required and that the patient recovered.This incident was captured under hillrom complaint ref # (b)(4).
 
Manufacturer Narrative
It was reported that the metal tip on the pro 6000 thermometer was getting excessively hot and burnt a patient¿s ear.Specific details of the reported burn were not provided, however, the customer reported that no medical intervention was required and that the patient recovered.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 patient was burned, no medical intervention was required, and the patient recovered.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.
 
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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 Key17583215
MDR Text Key321527022
Report Number1316463-2023-00185
Device Sequence Number1
Product Code FLL
UDI-Device Identifier00732094309003
UDI-Public732094309003
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number06000-200
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/04/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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