TPLC - Total Product Life Cycle

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Device	circuit, breathing (w connector, adaptor, y piece)
Product Code	CAI
Regulation Number	868.5240
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	271	271
Leak/Splash	267	267
Disconnection	175	175
Product Quality Problem	105	105
Crack	91	91
Break	51	51
Loose or Intermittent Connection	50	50
Material Puncture/Hole	45	45
Connection Problem	29	29
Component Missing	23	23
Defective Component	23	23
Material Deformation	23	23
Detachment of Device or Device Component	22	22
Air Leak	21	21
Obstruction of Flow	20	20
Fitting Problem	18	18
Device Operates Differently Than Expected	17	17
Failure to Deliver	16	16
Material Integrity Problem	16	16
Device Alarm System	15	15
Fracture	15	15
Contamination /Decontamination Problem	14	14
Insufficient Information	14	14
Material Split, Cut or Torn	14	14
Detachment Of Device Component	12	12
Fluid/Blood Leak	11	11
Material Separation	10	10
Inflation Problem	10	10
Occlusion Within Device	10	10
Incomplete or Missing Packaging	9	9
Melted	9	9
Tear, Rip or Hole in Device Packaging	8	8
Degraded	8	8
Hole In Material	8	8
Pressure Problem	8	8
Device Displays Incorrect Message	8	8
Material Twisted/Bent	7	7
Defective Device	7	7
Infusion or Flow Problem	7	7
Partial Blockage	6	6
No Flow	6	6
Device Damaged Prior to Use	6	6
Inadequacy of Device Shape and/or Size	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Moisture Damage	5	5
Improper Flow or Infusion	5	5
Output Problem	5	5
Moisture or Humidity Problem	5	5
Cut In Material	5	5
Gas Output Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	600	600
No Known Impact Or Consequence To Patient	234	234
No Patient Involvement	145	145
No Consequences Or Impact To Patient	137	137
Insufficient Information	77	77
Low Oxygen Saturation	23	23
No Information	14	14
Hypoxia	11	11
Respiratory Distress	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Unspecified Infection	8	8
Hypoventilation	7	7
Dyspnea	5	5
Bradycardia	5	5
Respiratory Insufficiency	4	4
Pressure Sores	4	4
Burn(s)	3	3
No Code Available	2	2
Decreased Respiratory Rate	2	2
Cyanosis	2	2
Extubate	2	2
Bacterial Infection	2	2
Viral Infection	2	2
Death	2	2
Awareness during Anaesthesia	2	2
Cardiopulmonary Arrest	2	2
Asphyxia	2	2
Respiratory Failure	1	1
Airway Obstruction	1	1
Irritability	1	1
Respiratory Distress Syndrome of Newborns	1	1
Headache	1	1
Patient Problem/Medical Problem	1	1
Unspecified Respiratory Problem	1	1
Pulmonary Hypertension	1	1
Pulmonary Edema	1	1
Balance Problems	1	1
Choking	1	1
Pain	1	1
Swelling	1	1
Foreign Body In Patient	1	1
Cardiac Tamponade	1	1
Cardiac Arrest	1	1
Apnea	1	1
Chemical Exposure	1	1
Perforation	1	1
Aspiration/Inhalation	1	1
Test Result	1	1
Arrhythmia	1	1
Brain Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Draeger Medical, Inc.	I	May-17-2023
2	GE Medical Systems, LLC	II	Sep-09-2009
3	Impact Instrumentation, Inc.	II	Jan-12-2012
4	Instrumentation Industries Inc	II	Dec-29-2013
5	Intersurgical Inc	II	Jun-27-2018
6	King Systems Corp.	I	Sep-27-2013
7	King Systems Corp.	II	Feb-03-2009
8	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-11-2024
9	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
10	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-28-2024
11	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-22-2024
12	MEDLINE INDUSTRIES, LP - Northfield	II	Jun-28-2024
13	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
14	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
15	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
16	Medline Industries Inc	II	Dec-18-2019
17	Teleflex Medical	I	Sep-30-2014
18	Teleflex Medical	II	Jul-23-2014