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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chamber, hyperbaric
Regulation Description Hyperbaric chamber.
Product CodeCBF
Regulation Number 868.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
FINK ENGINEERING PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
US HYPERBARIC NETWORK
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 6 6
2022 9 9
2023 13 13
2024 13 13
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Use of Device Problem 5 5
Decrease in Pressure 3 3
Mechanical Problem 3 3
No Apparent Adverse Event 3 3
Improper or Incorrect Procedure or Method 2 2
Key or Button Unresponsive/not Working 2 2
Insufficient Information 2 2
Fail-Safe Problem 2 2
Failure to Align 2 2
Complete Blockage 1 1
Electrical /Electronic Property Problem 1 1
Unexpected Therapeutic Results 1 1
Activation, Positioning or Separation Problem 1 1
Protective Measures Problem 1 1
Contamination /Decontamination Problem 1 1
Product Quality Problem 1 1
Increase in Pressure 1 1
Pressure Problem 1 1
Sharp Edges 1 1
Fail-Safe Did Not Operate 1 1
Emergency Power Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
Convulsion/Seizure 5 5
Insufficient Information 3 3
Dyspnea 2 2
Death 2 2
Cardiopulmonary Arrest 1 1
Pneumothorax 1 1
Headache 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Neuralgia 1 1
Memory Loss/Impairment 1 1
Transient Ischemic Attack 1 1
Total Hearing Loss 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Low Oxygen Saturation 1 1

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