MAUDE Adverse Event Report: WELCH ALLYN INC PRO6000 BULK PK THERMOMETERS 4TH EDITION; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 413071

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

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.Follow-up attempts were made with the customer; however, they could not provide any further details of burn type or medical intervention (if any) provided.It is noted the caretaker sustained a slight red mark to their left index finger.Follow up with the customer to determine severity of the event including injury/ burn type, medical intervention (if any), and patient outcome were unsuccessful.However, if the reported malfunction were to recur event were to recur it could result in serious injury if the device were to exceed a safe temperature threshold.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.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.

Event Description

The customer reported the pro 6000 had an overheated tip during use on a child with the customer sustaining a slight red mark to their left index finger and the child pending further examination of their left ear.It is noted by the customer that the thermometer was removed from its base, inserted into the child left ear, the child screamed, and the device was pulled away, the customer then touched the end and noted the hotness of the device tip.The customer states that the device did not provide any audible or visual messages/ alerts prior to the alleged event.The customer (caretaker) injury will be captured in this report (hillrom ref # (b)(4)).The patient (child) injury will be captured in a separate report (hillrom ref (b)(4)).

• Brand Name: PRO6000 BULK PK THERMOMETERS 4TH EDITION
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15122617
• MDR Text Key: 296899714
• Report Number: 1316463-2022-00111
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00732094293920
• UDI-Public: 732094293920
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 413071
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1