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 Discomfort (2330)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported the thermoscan pro 6000 was being used in the emergency department when the probe tip became hot causing mild discomfort to the patient during use of the device.No medical intervention was reported.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.It is believed that replication of the malfunction with the returned device 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.Discomfort is an unpleasant sensation occurring in varying degrees of severity and typically stops once the stimulus is removed.Discomfort may be contained to a discrete area as in an injury or more diffuse as in disorders or diseases.Discomfort is a symptom and not an injury.Pain or discomfort is not life threatening and does not require treatment to prevent a permanent impairment of a body function or structure and is not considered a serious injury.However, the reported malfunction could lead to a serious injury if the malfunction were to recur.Additionally, 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 thermoscan pro 6000 was being used in the emergency department when the probe tip became hot causing mild discomfort to the patient during use of the device.No medical intervention was reported.This report was filed in our complaint handling system as complaint # (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: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 12546723
• MDR Text Key: 273780036
• Report Number: 1316463-2021-00042
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/29/2021

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 Operator: Health Professional
• Device Model Number: 06000-200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 09/29/2021
• 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 Number: 1