TPLC - Total Product Life Cycle

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Device	nebulizer (direct patient interface)
Product Code	CAF
Regulation Number	868.5630
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADHERIUM (NZ) LTD
	SUBSTANTIALLY EQUIVALENT	6
AEROGEN LTD.
	SUBSTANTIALLY EQUIVALENT	1
AIREHEALTH INC.
	SUBSTANTIALLY EQUIVALENT	1
BREATHESUITE INC
	SUBSTANTIALLY EQUIVALENT	1
COGNITA LABS, LLC
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD.
	SUBSTANTIALLY EQUIVALENT	1
EXCELLENTCARE MEDICAL (HUIZHOU) LTD.
	SUBSTANTIALLY EQUIVALENT	1
FEELLIFE HEALTH INC.
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HCMED INNOVATIONS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MANKIND PHARMA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTIRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES LP
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
MONAGHAN MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OCHSNER CLINIC FOUNDATION
	SUBSTANTIALLY EQUIVALENT	1
PARI RESPIRATORY EQUIPMENT, INC.
	SUBSTANTIALLY EQUIVALENT	2
RECIPROCAL LABS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
THAYER MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
THE RITEDOSE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TRUDELL MEDICAL INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	2
VAPOTHERM INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Deliver	160	160
Connection Problem	55	55
Leak/Splash	44	44
Break	35	35
Disconnection	23	23
Mechanical Problem	19	19
Defective Device	18	18
Fluid/Blood Leak	18	18
Use of Device Problem	17	17
Improper Flow or Infusion	15	15
Failure to Infuse	14	14
Infusion or Flow Problem	13	13
Output Problem	13	13
Therapeutic or Diagnostic Output Failure	13	13
Fire	12	12
Adverse Event Without Identified Device or Use Problem	11	11
Insufficient Information	11	11
Patient Device Interaction Problem	11	11
Material Rupture	10	10
Defective Component	10	10
Melted	10	10
Gas/Air Leak	9	9
Smoking	8	8
Fitting Problem	8	8
Overheating of Device	8	8
Detachment of Device or Device Component	8	8
No Flow	7	7
Appropriate Term/Code Not Available	7	7
Electrical /Electronic Property Problem	7	7
Failure to Power Up	7	7
Unexpected Shutdown	6	6
Inaccurate Delivery	6	6
Insufficient Flow or Under Infusion	6	7
Loose or Intermittent Connection	6	6
Component Missing	5	5
Sparking	5	5
Contamination	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Degraded	5	5
Thermal Decomposition of Device	4	4
Product Quality Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Material Integrity Problem	4	4
Temperature Problem	4	4
Unexpected Therapeutic Results	4	4
Partial Blockage	3	3
Device Emits Odor	3	3
Obstruction of Flow	3	3
Corroded	3	3
Device Displays Incorrect Message	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	284	285
No Consequences Or Impact To Patient	149	149
Insufficient Information	72	72
No Known Impact Or Consequence To Patient	59	59
No Patient Involvement	52	52
Dyspnea	12	12
Low Oxygen Saturation	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Unspecified Respiratory Problem	7	7
Unintended Extubation	5	5
Aspiration/Inhalation	5	5
Swelling/ Edema	4	4
No Information	4	4
Increased Respiratory Rate	3	3
Asthma	3	3
Headache	3	3
Dizziness	3	3
Sore Throat	2	2
High Pulmonary Arterial Wedge Pressure	2	2
Urinary Frequency	2	2
Airway Obstruction	2	2
Bacterial Infection	2	2
Respiratory Distress	2	2
Fibrosis	2	2
Respiratory Insufficiency	2	2
Hypersensitivity/Allergic reaction	2	2
Itching Sensation	2	2
Pneumothorax	2	2
Arrhythmia	2	2
Hypoxia	2	2
Burn(s)	2	2
Apnea	2	2
Cyanosis	2	2
Chest Pain	2	2
Bradycardia	2	2
Pneumonia	2	2
Cough	2	2
Pulmonary Hypertension	2	2
Bronchospasm	2	2
Unspecified Infection	2	2
Hot Flashes/Flushes	1	1
Hemorrhage/Bleeding	1	1
Partial thickness (Second Degree) Burn	1	1
Ulcer	1	1
Low Blood Pressure/ Hypotension	1	1
Decreased Respiratory Rate	1	1
Underdose	1	1
Tachycardia	1	1
Pulmonary Edema	1	1
Heart Failure/Congestive Heart Failure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	I	Sep-14-2023
2	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company	I	Feb-04-2019
3	SANRAI INTERNATIONAL LLC	II	Mar-26-2019
4	Smiths Medical ASD Inc.	II	Apr-29-2021