MAUDE Adverse Event Report: WELCH ALLYN INC. SRV KIT, BRAUN PRO 6000 THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 105948

Device Problem Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.An error code or message is a safety indication feature of the device designed to alert the user/clinician of a possible device problem so the device user may take appropriate action, which may include removing the device from service.The clinician would be alerted to the error code/message by a visual indication and/or an audible alarm tone.The instructions for use (ifu) contains definitions of the error codes/messages for user reference.If the device displayed an error code/message before use on a patient, the clinician would be with the patient and would be aware that the device was not available for use.The clinician would then rely on their clinical assessment of the patient or obtain an alternative device.If the device displayed an error code/message during use, an alert would notify the clinician visually and/or audibly of the error code/message and the clinician would be informed to not utilize the device until the error code/message has been resolved.The clinician would then rely on their clinical assessment of the patient or obtain an alternative device.There was no serious incident reported and should the incident of error message recur, it is unlikely to cause or contribute to a serious incident for the reasons stated above.Therefore, hillrom does not consider reports of an error message reportable.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 that the probe tip of their braun pro6000 overheated and the device displayed an error code.There were no allegations of injury.This event was captured in our complaint handling system under hillrom ref # (b)(4).

• Brand Name: SRV KIT, BRAUN PRO 6000 THERMOMETER
• 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: 14406267
• MDR Text Key: 291708119
• Report Number: 1316463-2022-00068
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00732094215267
• UDI-Public: 732094215267
• 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: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 105948
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1