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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
OXAVITA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
OXYHEAL MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 5 5
2017 9 9
2018 5 5
2019 3 3
2020 4 4
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Device Displays Incorrect Message 2 2
Fail-Safe Problem 2 2
Burst Container or Vessel 2 2
Decrease in Pressure 2 2
Break 2 2
Mechanical Problem 2 2
Noise, Audible 2 2
Improper Flow or Infusion 1 1
Output Problem 1 1
Device Alarm System 1 1
Mechanics Altered 1 1
Pressure Problem 1 1
Detachment Of Device Component 1 1
Complete Blockage 1 1
Material Separation 1 1
Device Reprocessing Problem 1 1
Fire 1 1
Patient-Device Incompatibility 1 1
Improper Device Output 1 1
Fail-Safe Did Not Operate 1 1
Gas Output Problem 1 1
No Apparent Adverse Event 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Death 4 4
No Information 3 3
Convulsion/Seizure 2 2
Muscle Spasm(s) 1 1
No Code Available 1 1
No Patient Involvement 1 1
Myocardial Infarction 1 1
Patient Problem/Medical Problem 1 1
Low Oxygen Saturation 1 1
Cardiopulmonary Arrest 1 1
Fever 1 1
Hepatitis 1 1
Pain 1 1

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