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

Model Number 06000-200

Device Problem Excessive Heating (4030)

Patient Problem Blister (4537)

Event Date 06/12/2023

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.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.The report of a hot feeling of discomfort in the patient¿s ear is an unpleasant sensation occurring in varying degrees of severity and typically stops once the stimulus is removed.It was additionally reported that the nurse developed a blister after touching the hot tip of the thermometer.For the purposes of this evaluation, a burn resulting in a blister is categorized as a second-degree burn.This type of burn injures the top layer of skin (epidermis) as well as the tissue below the skin (dermis).Second-degree burns may be characterized by the development of blisters, red, splotchy appearance of the skin and pain can be severe.Second-degree burns limited to an area no larger than 3 inches (7.6 centimeters) in diameter are considered minor and are treated as such.These minor burns will usually heal without further treatment.There was no report of medical intervention required to preclude permanent impairment of body function or permanent damage to body structure, which concludes a serious injury did not occur in this case.If the reported problem of a hot probe tip were to recur, it could cause or contribute to a death or serious injury.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

It was reported by a nurse that the patient stated the probe tip of the pro 6000 ear thermometer was extremely hot.The thermometer was immediately removed from the patient¿s ear by the nurse and no injury to the patient was reported.No visual or audible alerts were noted prior to the event.After the thermometer was removed from the patient¿s ear, the nurse placed the ear tip on the top of her hand and it was very hot leaving a red circle, which turned into a blister.Per the nurse, no injury was associated with the reported event and no medical intervention was reported.This incident was captured under hillrom complaint ref #: (b)(4).

• 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: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17184165
• MDR Text Key: 317809364
• Report Number: 1316463-2023-00140
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00732094309003
• UDI-Public: 732094309003
• 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
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 06000-200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2023
• 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