TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ADHERIUM (NZ) LTD
	SUBSTANTIALLY EQUIVALENT	4
AEROGEN LTD.
	SUBSTANTIALLY EQUIVALENT	1
AIREHEALTH INC.
	SUBSTANTIALLY EQUIVALENT	1
BREATHESUITE INC
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD.
	SUBSTANTIALLY EQUIVALENT	1
ENCHANT TEK 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	2
JOYTECH HEALTHCARE 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
1. K220145 Monaghan medical filtered mouthpiece kit
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
VOLUNTIS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Deliver	110	110
Break	33	33
Connection Problem	30	30
Use of Device Problem	24	24
Mechanical Problem	22	22
Defective Device	20	20
Leak/Splash	18	18
Adverse Event Without Identified Device or Use Problem	18	18
Disconnection	17	17
Insufficient Information	16	16
Melted	15	15
Failure to Infuse	14	14
Improper Flow or Infusion	13	13
Fire	12	12
Output Problem	12	12
Therapeutic or Diagnostic Output Failure	12	12
Infusion or Flow Problem	11	11
Patient Device Interaction Problem	11	11
Fluid/Blood Leak	10	10
Smoking	10	10
Insufficient Flow or Under Infusion	8	9
Failure to Power Up	8	8
Appropriate Term/Code Not Available	8	8
Detachment of Device or Device Component	8	8
Gas/Air Leak	6	6
Component Missing	6	6
Loose or Intermittent Connection	6	6
Electrical /Electronic Property Problem	6	6
Unexpected Shutdown	6	6
Overheating of Device	6	6
Defective Component	6	6
Thermal Decomposition of Device	5	5
Degraded	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Contamination	5	5
Material Integrity Problem	5	5
No Flow	5	5
Product Quality Problem	4	4
Restricted Flow rate	4	4
Partial Blockage	4	4
Unexpected Therapeutic Results	4	4
Material Too Soft/Flexible	4	4
Sparking	4	4
Temperature Problem	4	4
Failure to Charge	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Device Emits Odor	3	3
Inaccurate Delivery	3	3
Material Rupture	3	3
Pressure Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	338	339
Insufficient Information	86	86
No Consequences Or Impact To Patient	52	52
No Known Impact Or Consequence To Patient	23	23
Low Oxygen Saturation	15	15
Dyspnea	15	15
No Patient Involvement	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Unspecified Respiratory Problem	8	8
Swelling/ Edema	6	6
Unintended Extubation	5	5
Aspiration/Inhalation	5	5
Respiratory Insufficiency	4	4
Dizziness	4	4
Chronic Obstructive Pulmonary Disease (COPD)	4	4
Cyanosis	3	3
Arrhythmia	3	3
Headache	3	3
Bacterial Infection	3	3
No Information	3	3
Increased Respiratory Rate	3	3
Asthma	3	3
Itching Sensation	3	3
Airway Obstruction	2	2
Fibrosis	2	2
Sore Throat	2	2
Urinary Frequency	2	2
Hypoxia	2	2
Cough	2	2
Bronchospasm	2	2
Pneumonia	2	2
Chest Pain	2	2
Rash	2	2
Burn(s)	2	2
Muscle Weakness	2	2
High Pulmonary Arterial Wedge Pressure	2	2
Pneumothorax	2	2
Hypersensitivity/Allergic reaction	2	2
Apnea	2	2
Pulmonary Hypertension	2	2
Unspecified Infection	2	2
Burning Sensation	1	1
Viral Infection	1	1
Eye Burn	1	1
Malaise	1	1
Pain	1	1
Peeling	1	1
Bradycardia	1	1
Acanthameba Keratitis	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	Smiths Medical ASD Inc.	II	Apr-29-2021