TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2014	50	50
2015	63	63
2016	22	22
2017	8	8
2018	39	39
2019	29	29
2020	6	6
2021	12	12
2022	18	18
2023	4	4
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	57	57
Disconnection	34	34
Detachment Of Device Component	20	20
Inflation Problem	17	17
Connection Problem	14	14
Break	7	7
Nonstandard Device	6	6
Material Integrity Problem	6	6
Obstruction of Flow	6	6
Insufficient Information	5	5
Material Deformation	5	5
Occlusion Within Device	5	5
Loose or Intermittent Connection	5	5
Decoupling	4	4
Kinked	4	4
Leak/Splash	4	4
No Flow	4	4
Fitting Problem	4	4
Defective Component	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Incorrect Device Or Component Shipped	3	3
Material Separation	3	3
Partial Blockage	3	3
Air Leak	2	2
Component Falling	2	2
Fluid/Blood Leak	2	2
Fracture	2	2
Hole In Material	2	2
Material Puncture/Hole	2	2
Misconnection	2	2
Infusion or Flow Problem	2	2
Device Dislodged or Dislocated	2	2
Device Contamination with Chemical or Other Material	2	2
Material Twisted/Bent	2	2
Device Markings/Labelling Problem	2	2
Failure to Unfold or Unwrap	2	2
Device Issue	2	2
Patient-Device Incompatibility	2	2
Contamination /Decontamination Problem	2	2
Patient Device Interaction Problem	2	2
Material Split, Cut or Torn	2	2
Failure to Seal	2	2
Incomplete or Inadequate Connection	1	1
Separation Problem	1	1
Material Too Soft/Flexible	1	1
Device Operates Differently Than Expected	1	1
Difficult to Open or Close	1	1
Difficult to Open or Remove Packaging Material	1	1
Component Missing	1	1
Out-Of-Box Failure	1	1
Inaccurate Delivery	1	1
Failure to Calibrate	1	1
Split	1	1
Failure to Disconnect	1	1
Malposition of Device	1	1
Appropriate Term/Code Not Available	1	1
Noise, Audible	1	1
Output Problem	1	1
Packaging Problem	1	1
Physical Property Issue	1	1
Scratched Material	1	1
Torn Material	1	1
Gas/Air Leak	1	1
Improper Flow or Infusion	1	1
Electrical Shorting	1	1
Electromagnetic Compatibility Problem	1	1
Loose	1	1
Migration or Expulsion of Device	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Rupture	1	1
Device Slipped	1	1
Unsealed Device Packaging	1	1
Delivered as Unsterile Product	1	1
Complete Blockage	1	1
Display or Visual Feedback Problem	1	1
Filling Problem	1	1
Fire	1	1
Restricted Flow rate	1	1
Use of Incorrect Control/Treatment Settings	1	1
Crack	1	1
Device Alarm System	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	95	95
No Known Impact Or Consequence To Patient	66	66
No Patient Involvement	31	31
No Clinical Signs, Symptoms or Conditions	20	20
Low Oxygen Saturation	13	13
Tissue Breakdown	4	4
No Information	4	4
Insufficient Information	4	4
Corneal Abrasion	3	3
Burn(s)	2	2
Death	2	2
Dyspnea	2	2
Skin Inflammation/ Irritation	2	2
Respiratory Insufficiency	2	2
Foreign Body In Patient	2	2
Complaint, Ill-Defined	2	2
Injury	2	2
Reaction	1	1
Loss of consciousness	1	1
Choking	1	1
Nasal Obstruction	1	1
Confusion/ Disorientation	1	1
Lethargy	1	1
Blister	1	1
No Code Available	1	1
Full thickness (Third Degree) Burn	1	1
Erythema	1	1
Foreign Body Sensation in Eye	1	1
Hemorrhage/Bleeding	1	1
Hypoxia	1	1
Unspecified Infection	1	1
Rash	1	1
Respiratory Distress	1	1
Skin Erosion	1	1
Swelling	1	1
Visual Disturbances	1	1
Conjunctivitis	1	1
Abnormal Blood Gases	1	1
Airway Obstruction	1	1
Cyanosis	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ConvaTec, Inc	II	May-24-2017
2	Convatec Inc.	II	Feb-15-2011
3	Intersurgical Inc	II	Dec-07-2017
4	King Systems Corp.	II	Apr-06-2011
5	POM Medical LLC	II	Oct-31-2019
6	Salter Laboratories, Division of Regulatory Affairs	II	Oct-26-2011
7	Salter Labs	II	Jul-23-2014
8	Smiths Medical	II	Jun-24-2011
9	Vital Signs Devices, a GE Healthcare Company	II	Jun-29-2011