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

Model Number	06000-300
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the probe tip of their braun pro6000 smoked/burned.There were no allegations of injury.The braun thermoscan® pro 6000 ear thermometer is indicated for the intermittent measurement of human body temperature.Hillrom 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 hillrom has not been able toreproduce the malfunction with returned devices from customer complaints because 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 or Problem Description
The customer reported that the probe tip of their braun pro6000 smoked/burned.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
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street; skaneateles falls NY 13153
• MDR Report Key: 11769952
• Report Number: 1316463-2021-00005
• Device Sequence Number: 17025910
• Product Code: FLL
• UDI-Device Identifier: 00732094309027
• UDI-Public: 732094309027
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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
• Operator of Device: No Information
• Device Model Number: 06000-300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1