TPLC - Total Product Life Cycle

• Device: set, tubing and support, ventilator (w harness)
• Product Code: BZO
• Regulation Number: 868.5975
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	84	84
2015	55	55
2016	56	56
2017	46	46
2018	26	26
2019	33	33
2020	30	30
2021	52	52
2022	66	66
2023	37	37
2024	11	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	101	101
Break	77	77
Disconnection	36	36
Device Issue	29	29
Crack	28	28
Leak/Splash	28	28
Hole In Material	26	26
Gas/Air Leak	20	20
Split	19	19
Device Operates Differently Than Expected	19	19
Detachment of Device or Device Component	16	16
Detachment Of Device Component	16	16
Mechanical Problem	13	13
Torn Material	11	11
Connection Problem	10	10
Fitting Problem	10	10
Fracture	10	10
Failure of Device to Self-Test	9	9
Material Integrity Problem	8	8
Loose or Intermittent Connection	7	7
Insufficient Information	6	6
Inadequacy of Device Shape and/or Size	5	5
Material Puncture/Hole	5	5
Air Leak	5	5
Device Displays Incorrect Message	4	4
Device Handling Problem	4	4
Physical Property Issue	3	3
Device Contamination with Chemical or Other Material	3	3
Device Dislodged or Dislocated	3	3
Use of Device Problem	3	3
Material Too Rigid or Stiff	3	3
Material Separation	3	3
Device Damaged Prior to Use	3	3
Defective Component	3	3
Nonstandard Device	3	3
Gas Output Problem	2	2
Overheating of Device	2	2
Melted	2	2
Component Missing	2	2
Collapse	2	2
Material Disintegration	2	2
Obstruction of Flow	2	2
Defective Device	2	2
Device Slipped	2	2
Stretched	2	2
Infusion or Flow Problem	2	2
Material Twisted/Bent	2	2
Mechanics Altered	1	1
No Flow	1	1
Adverse Event Without Identified Device or Use Problem	1	1
No Pressure	1	1
Packaging Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Improper Chemical Reaction	1	1
Improper Flow or Infusion	1	1
Temperature Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Torqued	1	1
Misassembly by Users	1	1
Tear, Rip or Hole in Device Packaging	1	1
Patient-Device Incompatibility	1	1
Contamination /Decontamination Problem	1	1
Material Fragmentation	1	1
Kinked	1	1
Failure To Adhere Or Bond	1	1
Bent	1	1
Partial Blockage	1	1
Component Falling	1	1
Thermal Decomposition of Device	1	1
Circuit Failure	1	1
Out-Of-Box Failure	1	1
Failure to Deliver	1	1
Shipping Damage or Problem	1	1
Occlusion Within Device	1	1
Physical Resistance/Sticking	1	1
Device Fell	1	1
Suction Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	142	142
No Patient Involvement	112	112
No Consequences Or Impact To Patient	101	101
No Known Impact Or Consequence To Patient	95	95
Low Oxygen Saturation	19	19
Insufficient Information	13	13
No Information	6	6
Bradycardia	6	6
Decreased Respiratory Rate	4	4
Skin Erosion	3	3
Foreign Body In Patient	2	2
No Code Available	2	2
Hemorrhage/Bleeding	2	2
Hypoventilation	2	2
Pulmonary Insufficiency	2	2
Rash	1	1
Respiratory Distress	1	1
Scar Tissue	1	1
Injury	1	1
Ventilator Dependent	1	1
Sore Throat	1	1
Chest Tightness/Pressure	1	1
Hypoxia	1	1
Anoxia	1	1
Apnea	1	1
Burn(s)	1	1
Cardiac Arrest	1	1
Cyanosis	1	1
Death	1	1
Erythema	1	1
Cough	1	1
Device Embedded In Tissue or Plaque	1	1
Not Applicable	1	1
Patient Problem/Medical Problem	1	1
Tissue Breakdown	1	1
Therapeutic Effects, Unexpected	1	1
Respiratory Acidosis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Draeger Medical, Inc.	I	May-17-2023
2	Draeger Medical, Inc.	II	Apr-10-2014
3	Fisher & Paykel Healthcare, Ltd.	I	May-20-2014
4	Fisher & Paykel Healthcare, Ltd.	I	Jan-03-2013
5	Hamilton Medical, Inc.	II	Jul-02-2015
6	Mallinckrodt Manufacturing LLC	I	Sep-09-2023
7	TELEFLEX MEDICAL INC	II	May-24-2022