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 Problem Apnea (1720)

Event Type  Injury  

Event Description

According to the complaint two patients received skin blisters after using the tcm4 for a sleep study.Two tcm4 monitors were sent to radiometer for evaluation but the customer did not know which of the two monitors were used for the study.This report concerns patient ref.(b)(6).Mdr reports for the other affected patient will be submitted with mdr reference 3002807968-2014-00055.

Manufacturer Narrative

Both units has been received and tested by radiometer.The units needed new batteries but apart from this all tests were passed.The sensor temperature was set to 43 degrees on both units and the site time was set to 10 hrs on one unit (b)(4) and 4 hrs on the other (b)(4).The sensor temperature was changed to 42 degrees c and the site time to 4 hrs before returning the units to the customer.According to the customer the user has received proper training and the operators manual was followed.This injury is evaluated as reportable, but based on the information currently available 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 ; 8273216
• MDR Report Key: 4255697
• MDR Text Key: 21332424
• Report Number: 3002807968-2014-00054
• Device Sequence Number: 1
• Product Code: LKD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• 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: 10/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR