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)

Event Date 04/01/2014

Event Type  Injury  

Event Description

The patient (a neonatal boy born in (b)(6) gestation week) received a burn mark on the right thigh.The temperature was set to 43 degrees celsius, and the electrode was placed on the same location for 7 hours.According to the operator's manual (tcm4/40 om page 6-12) the probe should be relocated after 4 hours at least.

• 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 (Section G): RADIOMETER AMERICA, INC.; 810 sharon dr.; westlake OH 44145 159
• Manufacturer Contact: 810 sharon dr.; westlake, OH 44145-1598
• MDR Report Key: 3879434
• MDR Text Key: 20324047
• Report Number: 1523456-2014-00002
• Device Sequence Number: 1
• Product Code: LKD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2014
• Distributor Facility Aware Date: 05/02/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other