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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, airway pressure (includes gauge and/or alarm)
Regulation Description Airway pressure monitor.
Product CodeCAP
Regulation Number 868.2600
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 6 6
2023 11 11
2024 11 11
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 5 5
Decrease in Pressure 4 4
Unintended Deflation 3 3
Device Emits Odor 3 3
Pressure Problem 2 2
Failure to Zero 2 2
Defective Device 2 2
Gas/Air Leak 2 2
Break 1 1
Output Problem 1 1
Device Markings/Labelling Problem 1 1
Defective Component 1 1
Contamination 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Microbial Contamination of Device 1 1
Key or Button Unresponsive/not Working 1 1
Unable to Obtain Readings 1 1
No Pressure 1 1
Inflation Problem 1 1
Incorrect Measurement 1 1
Device Contamination with Chemical or Other Material 1 1
Fracture 1 1
Inaccurate Information 1 1
Premature Indicator Activation 1 1
Display or Visual Feedback Problem 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
Insufficient Information 6 6
No Consequences Or Impact To Patient 2 2
No Information 1 1

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