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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 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Use of Device Problem 5 5
Mechanical Problem 3 3
Insufficient Information 3 3
Fail-Safe Did Not Operate 3 3
Key or Button Unresponsive/not Working 3 3
Decrease in Pressure 3 3
No Apparent Adverse Event 3 3
Fail-Safe Problem 2 2
Failure to Align 2 2
Improper or Incorrect Procedure or Method 2 2
Activation, Positioning or Separation Problem 1 1
Pressure Problem 1 1
Emergency Power Failure 1 1
Complete Blockage 1 1
Contamination /Decontamination Problem 1 1
Sharp Edges 1 1
Product Quality Problem 1 1
Increase in Pressure 1 1
Protective Measures Problem 1 1
Unexpected Therapeutic Results 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Convulsion/Seizure 5 5
Insufficient Information 4 4
Death 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Dyspnea 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Total Hearing Loss 1 1
Superficial (First Degree) Burn 1 1
Pneumothorax 1 1
Memory Loss/Impairment 1 1
Transient Ischemic Attack 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Cardiopulmonary Arrest 1 1
Partial thickness (Second Degree) Burn 1 1
Headache 1 1
Low Oxygen Saturation 1 1
Neuralgia 1 1

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