MAUDE Adverse Event Report: TC ELECTRODE

Model Number 945-605

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

Associated importer report - (b)(4).

Event 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.

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.

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
• Type of Device: TC ELECTRODE
• MDR Report Key: 8280617
• MDR Text Key: 134178226
• Report Number: 3002807968-2019-00002
• Device Sequence Number: 1
• Product Code: LPP
• UDI-Device Identifier: 05700699456052
• UDI-Public: (01)05700699456052(10)TQ01
• Combination Product (y/n): N
• PMA/PMN Number: K001866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 945-605
• Device Catalogue Number: 945-605
• Device Lot Number: TQ-01 027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2007
• 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
• Patient Outcome(s): Other