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 was 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 (b)(4).Mdr reports for the other affected patient will be submitted with mdr reference 3002807968-2014-00054.

• Brand Name: TRANSCUTANEOUS BLOOD GAS MONITOR
• Type of Device: TCM4 MONITORING SYSTEM
• Manufacturer (Section D): RADIOMETER MEDICAL APS; akandejev 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: 4356208
• MDR Text Key: 5178719
• Report Number: 1523456-2014-00008
• 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: 11/06/2014,10/08/2014

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2014
• Distributor Facility Aware Date: 10/08/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR