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TPLC
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show TPLC since
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Device
chamber, hyperbaric
Regulation Description
Hyperbaric chamber.
Product Code
CBF
Regulation Number
868.5470
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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