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

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

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

According to the complaint, a (b)(6) year old child received a small abrasion/skin reaction or burn on the arm after using the tcm4 for a sleep study.After a week it was still not healed.More info, including a picture of the injury, has been requested in order to further specify the type of injury.

Manufacturer Narrative

The monitor has been received and tested by radiometer and all tests were passed.The following warning is included in the operators manual p 6-2: "warning-risk of burns: do not allow the tcpco2/tcpo2 sensor temperature to exceed 43 degrees celsius for neonates and 44 degrees celsius for adults if sensors are attached to skin for more than four hours as this may otherwise cause burns.The temperature of the sensor was 43 degrees celsius.Info regarding how long the sensor was attached to the skin has been requested to determine if and if this event could be caused by a user error.It was mentioned in the complaint that the patient rolled onto the side where the sensor was attached.This could enhance the heating effect of the sensor.No info of treatment applied has been received.This injury is evaluated as reportable, but based on the info 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
• MDR Report Key: 4375994
• MDR Text Key: 5284269
• Report Number: 3002807968-2014-00033
• Device Sequence Number: 1
• Product Code: LKD
• Combination Product (y/n): N
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1