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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
Product CodeLKD
Regulation Number 868.2480
Device Class 2


Premarket Reviews
ManufacturerDecision
SENTEC AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 4 4
Off-Label Use 1 1
Smoking 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Calibration Problem 1 1
Device Handling Problem 1 1
Incorrect Measurement 1 1
Electrical /Electronic Property Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Burn(s) 3 3
Burn, Thermal 2 2
Localized Skin Lesion 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Radiometer Medical ApS II Apr-22-2020
2 SenTec AG II Sep-15-2023
3 SenTec AG II Jun-20-2023
4 SenTec AG II Oct-28-2022
5 SenTec AG II Feb-18-2021
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