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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, liquid-oxygen, portable
Product CodeBYJ
Regulation Number 868.5655
Device Class 2


Premarket Reviews
ManufacturerDecision
ESSEX INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 25 25
2015 34 34
2016 19 19
2017 18 18
2018 21 21
2019 24 24
2020 39 39
2021 7 7
2022 4 4
2023 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 55 55
Adverse Event Without Identified Device or Use Problem 37 37
Leak/Splash 22 22
Insufficient Information 17 17
Fire 16 16
Use of Device Problem 11 11
Device Operates Differently Than Expected 10 10
Defective Component 6 6
Improper or Incorrect Procedure or Method 5 5
Appropriate Term/Code Not Available 5 5
Device Emits Odor 3 3
Failure to Shut Off 3 3
Infusion or Flow Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Gas/Air Leak 2 2
Improper Flow or Infusion 2 2
Chemical Spillage 2 2
Detachment of Device or Device Component 2 2
Mechanical Problem 2 2
Moisture Damage 2 2
Sticking 2 2
Break 2 2
No Flow 2 2
No Pressure 1 1
Operating System Becomes Nonfunctional 1 1
Operating System Version or Upgrade Problem 1 1
Physical Property Issue 1 1
Temperature Problem 1 1
Ventilation Problem in Device Environment 1 1
Burst Container or Vessel 1 1
Component Falling 1 1
Crack 1 1
Device Expiration Issue 1 1
Filling Problem 1 1
Inaccurate Flow Rate 1 1
Device Maintenance Issue 1 1
Device Alarm System 1 1
Insufficient Flow or Under Infusion 1 1
Product Quality Problem 1 1
Inadequate Service 1 1
Device Markings/Labelling Problem 1 1
Activation, Positioning or Separation Problem 1 1
Out-Of-Box Failure 1 1
Failure to Deliver 1 1
Defective Device 1 1
Device Tipped Over 1 1
Device Operational Issue 1 1
Difficult to Open or Close 1 1
Material Integrity Problem 1 1
Naturally Worn 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 52 52
No Consequences Or Impact To Patient 37 37
Burn, Thermal 26 26
No Known Impact Or Consequence To Patient 18 18
Death 14 14
Cryogenic Burn 12 12
Low Oxygen Saturation 7 7
No Patient Involvement 6 6
No Code Available 5 5
Insufficient Information 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Chronic Obstructive Pulmonary Disease (COPD) 4 4
Hypoxia 3 3
Partial thickness (Second Degree) Burn 3 3
Full thickness (Third Degree) Burn 2 2
Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pulmonary Emphysema 2 2
Abrasion 2 2
Hyperglycemia 2 2
Low Blood Pressure/ Hypotension 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Fatigue 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Pain 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Distress 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Caustic/Chemical Burns 1 1
Chemical Exposure 1 1
Pulmonary Embolism 1 1
Decreased Respiratory Rate 1 1
Not Applicable 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Caire, Inc. I Dec-02-2022
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