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 Injury (2348)

Event Date 07/03/2014

Event Type  Injury  

Event Description

According to the complaint, a (b)(4) 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.

• 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: 4376022
• MDR Text Key: 5117036
• Report Number: 1523456-2014-00004
• Device Sequence Number: 1
• Product Code: LKD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2014

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: 08/13/2014
• Distributor Facility Aware Date: 07/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR