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

Model Number 06000-300

Device Problem Excessive Heating (4030)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the probe tip of their braun pro6000 overheated.There were no allegations of injury.The braun thermoscan® pro 6000 ear thermometer is indicated for the intermittent measurement of human body temperature.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.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.As a result of the health hazard evaluation, hillrom/welch allyn has decided to initiate a field action in the form of a customer notification letter.This notification letter is intended to: remind users of the correct cleaning procedures for the device and provide an updated cleaning guide, which summarizes the correct cleaning protocol reflecting the instructions in the ifu to minimize potential for liquid ingress.Inform users of the potential safety risk of inappropriate cleaning practices.Inform users of what visual signals to look for when using the device to minimize the potential exposure to overheating probe tips.

Event Description

The customer reported that the probe tip of their braun pro6000 overheated.There were no allegations of injury.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: PRO 6000 W/LARGE CRADLE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer Contact: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 12302196
• MDR Text Key: 265852037
• Report Number: 1316463-2021-00031
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00732094309027
• UDI-Public: 732094309027
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 06000-300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2021
• 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