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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, carbon-dioxide, cutaneous
Regulation Description Cutaneous carbon dioxide (PcCO2) monitor.
Product CodeLKD
Regulation Number 868.2480
Device Class 2

MDR Year MDR Reports MDR Events
2016 4 4
2019 3 3
2020 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 7 7
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Fire 1 1
Incorrect Measurement 1 1
Off-Label Use 1 1
Use of Device Problem 1 1
Out-Of-Box Failure 1 1
Thermal Decomposition of Device 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 4 4
Burning Sensation 3 3
Burn, Thermal 2 2
No Known Impact Or Consequence To Patient 2 2
Partial thickness (Second Degree) Burn 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Radiometer America Inc II May-02-2016
2 Radiometer Medical ApS II Apr-22-2020
3 SenTec AG II Feb-18-2021
4 SenTec AG II Aug-05-2019
5 SenTec AG II Oct-17-2016
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