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 importer report - (b)(4).
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.
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.
Additional Manufacturer Narrative
Based on the investigation performed of the electrode returned, the following is concluded.The electrode cable is damaged due to unknown mechanical forces or thermal power applied to the cable.The innerwires may have been short-circuited as aftermath effect of damaged cable.The electrode works as intended when the innerwires are not short circuited.The analysis has shown that short-circuited innerwires are unable to lead to any patient hazards or harms.Performed simulations have shown that the building safety mechanisms in the tcm400 monitor works as intended in a worse case scenario with the damaged electrode.Additional experiments with maximum possible currents have shown that the outer jacked temperature cannot be heated up to over safe 40 °c.Hereby, it is concluded that the damaged electrode, when used properly cannot be the root cause to the patient burn mark described in this complaint.The root cause cannot be determined.

• Brand Name: TC ELECTRODE
• Common Device Name: TC ELECTRODE
• MDR Report Key: 8280617
• Report Number: 3002807968-2019-00002
• Device Sequence Number: 13939855
• 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
• PMA/510(K) Number: K001866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2019

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
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 06/12/2019; 09/23/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 06/27/2019; 10/04/2019
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2007
• 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