MAUDE Adverse Event Report: RADIOMETER MEDICAL APS TRANSCUTANEOUS BLOOD GAS MONITOR; TCM TOSCA COMBI M

Model Number TCM4 SERIES

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

Patient Problems Burn(s) (1757); Injury (2348); Partial thickness (Second Degree) Burn (2694)

Event Date 03/08/2014

Event Type  Injury  

Event Description

The patient rec'd a second degree burn mark on the arm, after the tc sensor was removed.The temperature was set to 43 degrees celsius, and the electrode was placed on the same location for 60 minutes.According to the doctor, the patient was going through a septic shock, and this can lead to decreased blood circulation.

Manufacturer Narrative

According to the complaint, the temperature of the sensor was set to 43 degrees celsius and the sensor was relocated every 60 minutes.This is within the operator's manual for patients with normal blood circulation.However, in the operators manual there is a warning about always paying attention to the use of the sensors on patients in shock due to risk of skin damage.Warning - risk of skin damage.Long-term hyperthermia may blister skin.When producing local hyperemia by means of hyperthermia, a certain risk of applying temperatures harmful to the skin is always present, although the risk is limited due to the control system of the instrument.Always pay attention to the use of hyperthermia for special patients - e.G.Patients in shock, patients with low blood pressure, and patients with vascular constrictions.The placement of the sensor for 60 minutes could explain the burn mark on this patient.To analyze the case further the sensor will be investigated to see if a product malfunction also contributed to this case.

• Brand Name: TRANSCUTANEOUS BLOOD GAS MONITOR
• Type of Device: TCM TOSCA COMBI M
• 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: 3760957
• MDR Text Key: 4551074
• Report Number: 3002807968-2014-00014
• Device Sequence Number: 1
• Product Code: LKD
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2014

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
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• 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: 7.5 YR