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	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	110	110
Break	33	33
Connection Problem	30	30
Use of Device Problem	24	24
Mechanical Problem	22	22
Defective Device	20	20
Adverse Event Without Identified Device or Use Problem	18	18
Leak/Splash	18	18
Disconnection	17	17
Insufficient Information	16	16
Melted	15	15
Failure to Infuse	14	14
Improper Flow or Infusion	13	13
Output Problem	12	12
Fire	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
Failure to Power Up	8	8
Insufficient Flow or Under Infusion	8	9
Appropriate Term/Code Not Available	8	8
Detachment of Device or Device Component	8	8
Overheating of Device	6	6
Component Missing	6	6
Electrical /Electronic Property Problem	6	6
Defective Component	6	6
Loose or Intermittent Connection	6	6
Gas/Air Leak	6	6
Unexpected Shutdown	6	6
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Material Integrity Problem	5	5
No Flow	5	5
Degraded	5	5
Contamination	5	5
Thermal Decomposition of Device	5	5
Material Too Soft/Flexible	4	4
Temperature Problem	4	4
Sparking	4	4
Unexpected Therapeutic Results	4	4
Restricted Flow rate	4	4
Failure to Charge	4	4
Partial Blockage	4	4
Product Quality Problem	4	4
Material Rupture	3	3
Device Displays Incorrect Message	3	3
Pressure Problem	3	3
Device Emits Odor	3	3
Inaccurate Delivery	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
Unspecified Respiratory Problem	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Swelling/ Edema	6	6
Unintended Extubation	5	5
Aspiration/Inhalation	5	5
Chronic Obstructive Pulmonary Disease (COPD)	4	4
Respiratory Insufficiency	4	4
Dizziness	4	4
No Information	3	3
Headache	3	3
Cyanosis	3	3
Bacterial Infection	3	3
Asthma	3	3
Arrhythmia	3	3
Itching Sensation	3	3
Increased Respiratory Rate	3	3
Pneumonia	2	2
Pneumothorax	2	2
Rash	2	2
Pulmonary Hypertension	2	2
Cough	2	2
Airway Obstruction	2	2
Apnea	2	2
Muscle Weakness	2	2
Urinary Frequency	2	2
Fibrosis	2	2
Burn(s)	2	2
Chest Pain	2	2
Sore Throat	2	2
Bronchospasm	2	2
Hypersensitivity/Allergic reaction	2	2
Hypoxia	2	2
Unspecified Infection	2	2
High Pulmonary Arterial Wedge Pressure	2	2
Viral Infection	1	1
Wheezing	1	1
Ulcer	1	1
Respiratory Arrest	1	1
Heart Failure/Congestive Heart Failure	1	1
Partial thickness (Second Degree) Burn	1	1
Malaise	1	1
Missed Dose	1	1
Fungal Infection	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