TPLC - Total Product Life Cycle

show TPLC since

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
1. K201167 AireHealth NebulizerTM
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
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	25	25
Defective Device	23	23
Mechanical Problem	22	22
Adverse Event Without Identified Device or Use Problem	19	19
Leak/Splash	18	18
Insufficient Information	18	18
Disconnection	17	17
Melted	15	15
Failure to Infuse	14	14
Improper Flow or Infusion	13	13
Therapeutic or Diagnostic Output Failure	13	13
Fire	12	12
Output Problem	12	12
Smoking	12	12
Infusion or Flow Problem	11	11
Patient Device Interaction Problem	11	11
Fluid/Blood Leak	10	10
Insufficient Flow or Under Infusion	9	10
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
Temperature Problem	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
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	344	345
Insufficient Information	91	91
No Consequences Or Impact To Patient	52	52
No Known Impact Or Consequence To Patient	23	23
Low Oxygen Saturation	16	16
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
Aspiration/Inhalation	6	6
Unintended Extubation	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
Sore Throat	2	2
Urinary Frequency	2	2
Fibrosis	2	2
Hypoxia	2	2
Bronchospasm	2	2
Cough	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
Hypersensitivity/Allergic reaction	2	2
Pneumothorax	2	2
Apnea	2	2
Unspecified Infection	2	2
Pulmonary Hypertension	2	2
Burning Sensation	1	1
Eye Burn	1	1
Acanthameba Keratitis	1	1
Viral Infection	1	1
Malaise	1	1
Peeling	1	1
Pain	1	1
Bradycardia	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