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
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
Break	48	48
Defective Device	35	37
Use of Device Problem	28	28
Therapeutic or Diagnostic Output Failure	26	26
Adverse Event Without Identified Device or Use Problem	26	26
Mechanical Problem	23	23
Leak/Splash	20	20
Insufficient Information	18	18
Connection Problem	17	17
Melted	17	17
Patient Device Interaction Problem	16	16
Output Problem	16	16
Failure to Infuse	16	16
Disconnection	13	13
Obstruction of Flow	13	23
Infusion or Flow Problem	12	12
Smoking	11	12
Increase in Pressure	11	11
Component Missing	10	12
Detachment of Device or Device Component	10	20
Improper Flow or Infusion	9	10
Failure to Power Up	8	8
Insufficient Flow or Under Infusion	8	9
Defective Component	8	8
Fire	8	8
Unexpected Shutdown	8	8
Fluid/Blood Leak	8	8
Appropriate Term/Code Not Available	7	7
Loose or Intermittent Connection	7	7
Material Integrity Problem	6	6
Overheating of Device	6	6
Gas/Air Leak	6	6
Fitting Problem	6	6
Restricted Flow rate	5	5
Partial Blockage	5	5
Unexpected Therapeutic Results	5	5
Contamination	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Electrical /Electronic Property Problem	5	5
No Flow	5	15
Thermal Decomposition of Device	5	5
Temperature Problem	5	5
Inaccurate Delivery	4	4
Product Quality Problem	4	14
Protective Measures Problem	4	5
Material Too Soft/Flexible	4	4
Failure to Charge	4	4
Device Emits Odor	3	3
Material Rupture	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	398	414
Insufficient Information	141	141
Low Oxygen Saturation	19	19
Dyspnea	18	19
Unspecified Respiratory Problem	11	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Swelling/ Edema	6	6
Aspiration/Inhalation	6	6
Unintended Extubation	5	5
Chronic Obstructive Pulmonary Disease (COPD)	5	5
Bronchospasm	4	4
Pneumonia	4	4
Dizziness	4	4
Unspecified Infection	3	3
Cyanosis	3	3
Increased Respiratory Rate	3	3
Arrhythmia	3	3
Cough	3	3
Hypoxia	3	3
Bacterial Infection	3	3
Respiratory Insufficiency	3	3
Headache	3	3
Itching Sensation	3	3
Asthma	3	4
Pulmonary Edema	2	2
Heart Failure/Congestive Heart Failure	2	2
Viral Infection	2	2
Chest Pain	2	2
Urinary Frequency	2	2
Rash	2	2
Sore Throat	2	2
Pulmonary Emphysema	2	2
Muscle Weakness	2	2
Loss of consciousness	2	2
High Pulmonary Arterial Wedge Pressure	2	2
Airway Obstruction	2	2
Hypersensitivity/Allergic reaction	2	2
Decreased Respiratory Rate	2	2
Pneumothorax	2	2
Apnea	2	2
Respiratory Failure	2	2
Bronchitis	2	2
Sleep Dysfunction	2	3
Fibrosis	1	1
Hot Flashes/Flushes	1	1
No Consequences Or Impact To Patient	1	1
Partial thickness (Second Degree) Burn	1	1
Ulcer	1	1
Low Blood Pressure/ Hypotension	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