TPLC - Total Product Life Cycle

• Device: unit, liquid-oxygen, portable
• Regulation Description: Portable liquid oxygen unit.
• Product Code: BYJ
• Regulation Number: 868.5655
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2020	39	39
2021	7	7
2022	4	4
2023	10	10
2024	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	27	27
Leak/Splash	10	10
Fire	8	8
Use of Device Problem	8	8
Defective Component	6	6
Insufficient Information	4	4
Mechanical Problem	2	2
Gas/Air Leak	2	2
Infusion or Flow Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Detachment of Device or Device Component	2	2
Improper or Incorrect Procedure or Method	2	2
Activation, Positioning or Separation Problem	1	1
Burst Container or Vessel	1	1
Crack	1	1
Defective Device	1	1
Material Integrity Problem	1	1
No Pressure	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cryogenic Burn	19	19
Burn(s)	17	17
Burn, Thermal	11	11
No Consequences Or Impact To Patient	6	6
No Clinical Signs, Symptoms or Conditions	5	5
Insufficient Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Death	3	3
Full thickness (Third Degree) Burn	3	3
Hypoxia	2	2
Abrasion	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
No Known Impact Or Consequence To Patient	1	1
Hyperglycemia	1	1
Partial thickness (Second Degree) Burn	1	1
Hemorrhage/Bleeding	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1

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