MAUDE Adverse Event Report: RADIOMETER MEDICAL APS; MONITOR, CARBON-DIOXIDE, CUTANEOUS

Device Problem Calibration Problem (2890)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

A radiometer medical aps tcm tosca monitor was not working properly.The monitor would only read a number of 40 after being calibrated multiple times.The malfunctioning transcutaneous monitor was removed from patient care.

• Type of Device: MONITOR, CARBON-DIOXIDE, CUTANEOUS
• Manufacturer (Section D): RADIOMETER MEDICAL APS; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 12998800
• MDR Text Key: 282199101
• Report Number: 12998800
• Device Sequence Number: 1
• Product Code: LKD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA