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
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
FINDAIR SP. Z O.O.
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LIMITED
	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, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	2
MONAGHAN MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OCHSNER CLINIC FOUNDATION
	SUBSTANTIALLY EQUIVALENT	1
PARI RESPIRATORY EQUIPMENT, INC.
	SUBSTANTIALLY EQUIVALENT	2
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JERMEI MEDICAL DEVICE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THAYER MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
THE RITEDOSE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TRUDELL MEDICAL INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
VAPOTHERM, INC.
	SUBSTANTIALLY EQUIVALENT	1
VOLUNTIS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Deliver	88	88
Infusion or Flow Problem	67	67
No Flow	41	41
Restricted Flow rate	32	32
Pressure Problem	28	28
Adverse Event Without Identified Device or Use Problem	28	28
Break	25	25
Use of Device Problem	24	24
Fluid/Blood Leak	24	24
Leak/Splash	22	22
Connection Problem	21	21
Insufficient Heating	21	37
Fitting Problem	19	19
Decrease in Pressure	19	19
Melted	19	19
Detachment of Device or Device Component	18	18
Disconnection	17	17
Output Problem	16	16
Crack	16	16
Failure to Power Up	15	15
Insufficient Device Problem Information	14	14
Failure to Infuse	14	14
Loose or Intermittent Connection	13	13
Obstruction of Flow	12	12
Mechanical Problem	12	12
Smoking	12	13
Increase in Pressure	11	11
Noise, Audible	10	10
Gas/Air Leak	10	10
Overheating of Device	10	10
Insufficient Flow or Under Infusion	9	10
Defective Device	9	9
Material Integrity Problem	7	7
Electrical /Electronic Property Problem	7	23
Unexpected Shutdown	7	7
Therapeutic or Diagnostic Output Failure	6	6
Contamination	6	6
Gas Output Problem	6	6
Thermal Decomposition of Device	6	6
Fire	6	6
Appropriate Device Problem Term/Code Not Available	6	6
Damaged Thread	5	21
Patient Device Interaction Problem	5	5
No Pressure	5	5
Packaging Problem	5	5
Component Missing	5	5
Output below Specifications	5	5
Improper Flow or Infusion	5	5
Temperature Problem	5	5
Device Emits Odor	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	792	824
Insufficient Information	175	175
Low Oxygen Saturation	24	24
Dyspnea	18	19
Unspecified Respiratory Problem	17	19
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Bronchospasm	9	9
Pneumonia	7	7
Swelling/ Edema	6	6
Aspiration/Inhalation	6	6
Chronic Obstructive Pulmonary Disease (COPD)	6	6
Unintended Extubation	5	5
Dizziness	4	4
Cyanosis	3	3
Unspecified Infection	3	3
Cough	3	3
Increased Respiratory Rate	3	3
Arrhythmia	3	3
Hypoxia	3	3
Bacterial Infection	3	3
Respiratory Insufficiency	3	3
Asthma	3	4
Itching Sensation	3	3
Headache	3	3
Pulmonary Edema	2	2
Heart Failure/Congestive Heart Failure	2	2
Viral Infection	2	2
Chest Pain	2	2
Rash	2	2
Urinary Frequency / Polyuria	2	2
Sore Throat	2	2
Loss of consciousness	2	2
Pulmonary Emphysema	2	2
Airway Obstruction	2	2
High Pulmonary Arterial Wedge Pressure	2	2
Respiratory Failure	2	2
Decreased Respiratory Rate	2	2
Pneumothorax	2	2
Hypersensitivity/Allergic reaction	2	2
Apnea	2	2
Bronchitis	2	2
Sleep Dysfunction	2	3
Muscle Weakness/Atrophy	2	2
Hot Flashes/Flushes	1	1
Partial thickness (Second Degree) Burn	1	1
No Consequences Or Impact To Patient	1	1
Fibrosis	1	1
Ulcer	1	1
Infective Keratitis	1	1
Tachycardia	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