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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 12/01/2021
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the probe tip of their braun pro6000 overheated and burned patient¿s ear canal.The reported burn was noted to be a surface burn to the patient's inner ear.Details of medical intervention were requested but not provided.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.The pro 6000 technology reads the infrared energy emitted by the tympanic membrane and surrounding tissues to determine the patient¿s temperature.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 accurate measurement can be taken.An inspection of the device by the facility after its use for the measurement found a crack in the device's sensor tip.The device's ifu states if the probe lens window is damaged return to hillrom/welch allyn for service.A surface/superficial /first-degree burn injures the top layer of skin (epidermis) and causes the tissue below the skin (dermis) to become red and swollen.These minor burns will usually heal without further treatment.First-degree burn are considered as a minor burn unless it involves substantial portions of the hands, feet, face, groin, buttocks, or a major joint.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.Although this reported event did not result in serious injury, based on hillrom¿s ability to replicate the malfunction of a ¿hot tip¿ on new devices, that can exceed a safe temperature threshold and cause a more serious injury, we have deemed this complaint reportable.
 
Event Description
The customer reported that the probe tip of their braun pro6000 overheated and burned patient¿s ear canal.The reported burn was noted to be a surface burn to the patient's inner ear.Details of medical intervention were requested but not provided.This report was filed in our complaint handling system as complaint (b)(4).
 
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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
skaneateles falls NY 13153
Manufacturer Contact
antonio acquafredda
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key12974767
MDR Text Key283975142
Report Number1316463-2021-00086
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 Health Professional,User Facility
Reporter Occupation Other
Remedial Action Notification
Type of Report Initial
Report Date 12/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
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 Received12/01/2021
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 Number1
Patient SexMale
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