TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2019	24	24
2020	39	39
2021	7	7
2022	4	4
2023	10	10
2024	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	48	48
Leak/Splash	11	11
Fire	8	8
Use of Device Problem	8	8
Defective Component	6	6
Insufficient Information	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Mechanical Problem	2	2
Infusion or Flow Problem	2	2
Detachment of Device or Device Component	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
Gas/Air Leak	1	1
Improper or Incorrect Procedure or Method	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	21	21
Cryogenic Burn	18	18
Burn(s)	17	17
Burn, Thermal	16	16
No Clinical Signs, Symptoms or Conditions	5	5
Insufficient Information	5	5
No Known Impact Or Consequence To Patient	4	4
Death	3	3
Full thickness (Third Degree) Burn	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hypoxia	2	2
No Code Available	1	1
Abrasion	1	1
Chronic Obstructive Pulmonary Disease (COPD)	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