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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
OXAVITA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
US HYPERBARIC NETWORK
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 4 4
2021 6 6
2022 9 9
2023 13 13
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Decrease in Pressure 4 4
Use of Device Problem 3 3
Mechanical Problem 3 3
Fail-Safe Problem 2 2
Key or Button Unresponsive/not Working 2 2
Output Problem 1 1
Protective Measures Problem 1 1
Material Split, Cut or Torn 1 1
Sharp Edges 1 1
Fail-Safe Did Not Operate 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Align 1 1
Contamination /Decontamination Problem 1 1
Activation, Positioning or Separation Problem 1 1
Product Quality Problem 1 1
Unexpected Therapeutic Results 1 1
Complete Blockage 1 1
Electrical /Electronic Property Problem 1 1
Emergency Power Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Convulsion/Seizure 3 3
Death 2 2
Dyspnea 2 2
Headache 1 1
Memory Loss/Impairment 1 1
Muscle Spasm(s) 1 1
Myocardial Infarction 1 1
Pneumothorax 1 1
Transient Ischemic Attack 1 1
No Consequences Or Impact To Patient 1 1
Low Oxygen Saturation 1 1
No Patient Involvement 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 1 1
Neuralgia 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Total Hearing Loss 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cardiopulmonary Arrest 1 1

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