TPLC - Total Product Life Cycle

• Device: mask, oxygen
• Regulation Description: Oxygen mask.
• Product Code: BYG
• Regulation Number: 868.5580
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	6	6
2021	12	12
2022	18	18
2023	4	4
2024	9	9
2025	19	19

Device Problems	MDRs with this Device Problem	Events in those MDRs
Connection Problem	10	10
Detachment of Device or Device Component	8	8
Material Split, Cut or Torn	7	7
Break	4	4
Gas/Air Leak	4	4
Material Puncture/Hole	3	3
Defective Component	3	3
Material Deformation	3	3
Failure to Seal	3	3
Leak/Splash	2	2
Incomplete or Inadequate Connection	2	2
Insufficient Information	2	2
Material Integrity Problem	2	2
Patient Device Interaction Problem	2	2
Inflation Problem	2	2
Fracture	2	2
Device Dislodged or Dislocated	2	2
Loose or Intermittent Connection	2	2
Fitting Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Alarm System	1	1
Device Markings/Labelling Problem	1	1
Filling Problem	1	1
Patient-Device Incompatibility	1	1
Unsealed Device Packaging	1	1
Material Too Rigid or Stiff	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Improper Flow or Infusion	1	1
Infusion or Flow Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Delivered as Unsterile Product	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Separation	1	1
Electrical Shorting	1	1
Inaccurate Delivery	1	1
Failure to Calibrate	1	1
Appropriate Term/Code Not Available	1	1
Display or Visual Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	42	42
Low Oxygen Saturation	9	9
Insufficient Information	4	4
Tissue Breakdown	3	3
Corneal Abrasion	2	2
Skin Inflammation/ Irritation	2	2
No Known Impact Or Consequence To Patient	2	2
Respiratory Insufficiency	2	2
Cyanosis	1	1
Emotional Changes	1	1
Blister	1	1
Confusion/ Disorientation	1	1
Discomfort	1	1
Dyspnea	1	1
Choking	1	1
Hypoxia	1	1
No Consequences Or Impact To Patient	1	1
Loss of consciousness	1	1
Lethargy	1	1