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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2021

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.However, the hillrom manufacturing site has recently been able to reproduce the hot probe tip malfunction, with new devices, when the devices are subjected to various cleaners in an aggressive cleaning simulation.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.Hillrom has opened a capa and is investigating the root cause of the confirmed malfunction.As part of the capa hillrom will determined appropriate corrective actions as well as determine through our risk management process based on the capa investigation if further field safety action is required.

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/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: 12217603
• MDR Text Key: 263164366
• Report Number: 1316463-2021-00028
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00732094309003
• UDI-Public: 732094309003
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2021

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: No Information
• Device Model Number: 06000-200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/23/2021
• 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