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 manufacturers report - 3002807968-2019-00002.

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.

Event 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.

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
• Type of Device: TC ELECTRODE
• MDR Report Key: 8280937
• MDR Text Key: 134186747
• Report Number: 1523456-2019-00001
• Device Sequence Number: 1
• Product Code: LPP
• UDI-Device Identifier: 05700699456052
• UDI-Public: (01)05700699456052(10)TQ01
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 01/25/2019,06/26/2019

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2019
• Distributor Facility Aware Date: 01/07/2019
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other