MAUDE Adverse Event Report: TC PO2/PCO2 ELECTRODE

Model Number 945-377

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Date 12/24/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: is estimated based on manufacturer awareness date.It is presently unknown whether it was a healthcare professional handling the patient.However, it is not possible to mark 'no information.'.

Event Description

According to the complaint, the skin of the patient was slightly burned during transcutaneous oxygen/carbon dioxide measurement ultimately leaving a red mark and a blister.

Manufacturer Narrative

From the investigation, the root cause could not be established.

• Brand Name: TC PO2/PCO2 ELECTRODE
• Type of Device: TC PO2/PCO2 ELECTRODE
• MDR Report Key: 8234891
• MDR Text Key: 132810840
• Report Number: 3002807968-2019-00001
• Device Sequence Number: 1
• Product Code: LKD
• UDI-Device Identifier: 05700699453778
• UDI-Public: (01)05700699453778(10)XP04
• Combination Product (y/n): N
• PMA/PMN Number: K093154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 945-377
• Device Catalogue Number: 945-377
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other