MAUDE Adverse Event Report: TCM4 COMBI MODULE

Model Number 902-778

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

Please note that the incident date stated is best estimation.Furthermore, please also note catalog number is best estimation as this information is not known in the complaint.Unfortunately also the serial number, udi number and manufacturing date of the device is still unknown.The information will be added in a follow-up mdr when known.

Event Description

A customer reported bruising and redness on both legs bilaterally where the tcm sites were placed on an elgan (extremely low gestational ages newborn) (b)(6) weeks old newborn.The doctor felt the skin was so concerning and ordered for a wound consultant.

Manufacturer Narrative

It was informed by the radiometer representative that the hospital is using sensor 54 (item number: 945-736 manufactured by radiometer basel ag) with fixation ring 32 mm (item number: 5601500 manufactures by radiometer basel ag) in combination with the tcm combim monitor.More information has been asked from radiometer to the customer for the further investigation.

Manufacturer Narrative

It is not possible to conclude on an investigation based on the available information in this case.The operator's manual describes that the smaller n20 fixation or adhesive ring should be used for neonates.The smaller ring may be more gentle to the skin due to the smaller adhesive surface.It was recommended to the customer to try this smaller ring instead of the 32mm ring for this patient population.The customer has informed that they will continue to use the larger fixation rings, despite radiometer's recommendation.

• Brand Name: TCM4 COMBI MODULE
• Type of Device: TCM4 COMBI MODULE
• MDR Report Key: 10137122
• MDR Text Key: 195585938
• Report Number: 3002807968-2020-00020
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 902-778
• Device Catalogue Number: 902-778
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other