MAUDE Adverse Event Report: TC SENSOR 84

Model Number	945-737
Medical Device Problem Codes	Off-Label Use (1494); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complaint, the skin of the patient started to show redness/slight burn under the sensor during the device measurement ultimately leaving a blister.Staff reduced temp from 44'c to 40'c during the examination in the event that the heat of the sensor was the issue.
Additional Manufacturer Narrative
The investigation concluded that the nursing staff kept the sensor on the same spot without changing the location as per tcm protocol.In addition, the research by the site found the sensor temperature was changed to 37c after the warmer was removed from the flap site which again was not following the instructions.The sensor was kept in a single spot with maximum temperature of 41c for more than 24 hours.According to the team lead research physician at the site where the event happened, the customers internal investigation shows no indication that the radiometer device failed.This event only happened because of user error by the nursing staff.

• Brand Name: TC SENSOR 84
• Common Device Name: TC SENSOR 84
• MDR Report Key: 10028382
• Report Number: 3002807968-2020-00018
• Device Sequence Number: 19803782
• Product Code: LKD
• UDI-Device Identifier: 05700699457370
• UDI-Public: 05700699457370
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 945-737
• Device Catalogue Number: 945-737
• Device Lot Number: 811121
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 09/14/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other