MAUDE Adverse Event Report: WELCH ALLYN INC. PRO 6000 W/LARGE CRADLE; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	06000-300
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a nurse was using the pro 6000 thermometer and the tip/probe was hot and burned the patient¿s ear.The patient felt pain, but there was no visible burn mark, and the customer stated the patient was not injured.This event was captured under hillrom complaint ref #: (b)(4).
Additional Manufacturer Narrative
The braun/welch allyn 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 braun/welch allyn 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.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.The unit was returned for inspection where the reported malfunction of hot probe tip could not be replicated however it was determined that the 'perfecttemp' technology was not working on the device.It is believed that replication of the "hot probe tip" 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.Pain may be a symptom due to preexisting injury contained to a discrete area or a symptom felt more diffusely due to disorder or disease; however, pain is not an injury of itself.Pain is an unpleasant sensation that typically stops once the stimulus is removed.Pain is not life threatening.In this event, there was no report of medical intervention required to preclude permanent impairment of a body function or permanent damage to a body structure, concluding no serious injury occurred (negligible injury).However, a hot probe tip could lead to a serious injury if the malfunction were to recur.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 more serious injury we have deemed this complaint to be reportable.

• Brand Name: PRO 6000 W/LARGE CRADLE
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street; skaneateles NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16032797
• Report Number: 1316463-2022-00182
• Device Sequence Number: 7184421
• Product Code: FLL
• UDI-Device Identifier: 00732094309027
• UDI-Public: 732094309027
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

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: 06000-300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown