MAUDE Adverse Event Report: RADIOMETER MEDICAL APS TRANSCUTANEOUS BLOOD GAS MONITOR; TCM4 MONITORING SYSTEM

Model Number TCM4 SERIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Injury (2348); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

According to the complaint skin blisters were received after using the tcm4 sensor for 9 hours at the same location with the temperature set at 45 degrees.10 patients were affected.Currently, the patient information received for all patients is identical.More information has been requested.This report regards patient nr 3.Mdr reports for the affected patients will be submitted with mdr reference 3002807968-2014-00023 to 3002807968-2014-00032.

Manufacturer Narrative

The electrode has been requested sent back for investigation to determine if this problem has been caused by a product malfunction or a user error.Based on the event description this case could be caused by a user error since the electrode temperature was set higher than recommended and for 9 hours instead of only 4 hours.It will be determined if this event was caused by a product malfunction or a user error when the electrode has been investigated.Based on the pictures received the blisters are evaluated to be second degree burn marks.No information of treatment applied has been received.This injury is evaluated as reportable, but the injury is only evaluated as minor as it does not meet the criteria of a serious injury, as described in the instructions for this form.

• Brand Name: TRANSCUTANEOUS BLOOD GAS MONITOR
• Type of Device: TCM4 MONITORING SYSTEM
• Manufacturer (Section D): RADIOMETER MEDICAL APS; akandevej 21; bronshoj DK-2 700; DA DK-2700
• Manufacturer Contact: akandevej 21; bronshoj DK-27-00
• MDR Report Key: 3976234
• MDR Text Key: 15114707
• Report Number: 3002807968-2014-00025
• Device Sequence Number: 1
• Product Code: LKD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K043003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TCM4 SERIES
• Device Catalogue Number: 391-880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1