MAUDE Adverse Event Report: TC ELECTRODE

Model Number	945-605
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Associated manufacturers report - 3002807968-2019-00002.
Event or Problem Description
According to the complaint received, a patient sensor burn from a tcpo2 sensor used with a tcm400 monitor was reported.A (b)(6) year-old female patient being treated for chronic refractory osteomyelitis was subjected to in-chamber treatment on (b)(6) 2019, where a tcm400 monitor was applied.On (b)(6) 2019 the patient came back from hyperbaric oxygen treatment and a wound was identified on her leg in the area where the sensor was placed.The patient was admitted to the wound care center where the wound currently is being treated.
Event or Problem Description
A 48 year-old female patient being treated for chronic refractory osteomyelitis was subjected to in-chamber treatment on (b)(6) 2019, where a tcm400 monitor was applied.On (b)(6) 2019 the patient came back from hyperbaric oxygen treatment and a wound was identified on her leg in the area of where the sensor was placed.The patient was admitted to the wound care center where the wound currently is being treated.According to the complaint received, a patient sensor burn from a tcm400 monitor was reported.A 48 year-old female patient being treated for chronic refractory osteomyelitis was subjected to in-chamber treatment on (b)(6) 2019, where a tcm400 monitor was applied.On (b)(6) 2019 the patient came back from hyperbaric oxygen treatment and a wound was identified on her leg in the area of where the sensor was placed.The patient was admitted to the wound care center where the wound currently is being treated.
Additional Manufacturer Narrative
The affected electrode was tested in a monitor and calibrated, hereafter it measured correctly.The tc-electrode will be sent to production for additional testing.

• Brand Name: TC ELECTRODE
• Common Device Name: TC ELECTRODE
• MDR Report Key: 8280937
• Report Number: 1523456-2019-00001
• Device Sequence Number: 1686221
• Product Code: LPP
• UDI-Device Identifier: 05700699456052
• UDI-Public: (01)05700699456052(10)TQ01
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019
• Report Date (Section F): 01/25/2019

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: No Information
• Device Model Number: 945-605
• Device Catalogue Number: 945-605
• Device Lot Number: TQ-01 027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/07/2019
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/25/2019