TPLC - Total Product Life Cycle

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Device	humidifier, respiratory gas, (direct patient interface)
Regulation Description	Respiratory gas humidifier.
Product Code	BTT
Regulation Number	868.5450
Device Class	2

Premarket Reviews
Manufacturer	Decision
FISHER & PAYKEL HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	3
FISHER & PAYKEL HEALTHCARE, LTD.
	SUBSTANTIALLY EQUIVALENT	11
FLEXICARE MEDICAL LIMITED.
	SUBSTANTIALLY EQUIVALENT	1
HOMETA, INC.
	SUBSTANTIALLY EQUIVALENT	1
INVENT MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LABORATORIOS BIOGALENIC S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	3
PERMA PURE, LLC
	SUBSTANTIALLY EQUIVALENT	1
1. K193411 O2asis Personal Oxygen Humidifier
TELESAIR, INC.
	SUBSTANTIALLY EQUIVALENT	1
TNI MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
VAPOTHERM, INC.
	SUBSTANTIALLY EQUIVALENT	3
VINCENT HEALTHCARE PRODUCTS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Audible Alarm	3307	3307
Defective Alarm	2561	2564
Material Split, Cut or Torn	632	637
Detachment of Device or Device Component	477	488
Crack	402	406
Leak/Splash	389	392
Fluid/Blood Leak	314	315
Insufficient Heating	309	309
Failure to Power Up	183	183
Break	157	167
Gas/Air Leak	136	136
Mechanical Problem	97	98
Complete Loss of Power	83	83
Melted	77	77
Device Alarm System	75	75
Power Problem	58	58
Stretched	55	56
Adverse Event Without Identified Device or Use Problem	52	52
Insufficient Device Problem Information	50	50
Temperature Problem	45	45
Overfill	38	38
Device Dislodged or Dislocated	35	35
Disconnection	28	28
Use of Device Problem	27	27
Overheating of Device	26	26
Material Puncture/Hole	25	25
No Apparent Adverse Event	22	22
Infusion or Flow Problem	21	21
Obstruction of Flow	19	19
Improper Flow or Infusion	18	18
Misconnection	18	18
Moisture or Humidity Problem	16	16
Material Integrity Problem	16	16
Unintended Movement	14	14
Connection Problem	14	15
Loose or Intermittent Connection	14	14
Difficult to Open or Close	14	14
Contamination /Decontamination Problem	13	13
Appropriate Device Problem Term/Code Not Available	13	13
Fire	12	12
Intermittent Loss of Power	11	11
Failure to Read Input Signal	11	11
Device Handling Problem	10	10
Sparking	10	10
Device Sensing Problem	10	10
No Flow	9	9
Insufficient Flow or Under Infusion	8	8
Corroded	8	9
False Alarm	8	8
Material Deformation	7	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6976	7011
No Patient Involvement	1279	1279
No Known Impact Or Consequence To Patient	920	922
Low Oxygen Saturation	338	340
No Consequences Or Impact To Patient	319	320
Insufficient Information	127	128
Death	25	25
Hypoxia	19	19
Burn(s)	18	18
No Information	14	14
Bradycardia	13	13
Partial thickness (Second Degree) Burn	11	11
Cardiac Arrest	10	10
Superficial (First Degree) Burn	8	8
Airway Obstruction	8	8
Respiratory Distress	7	7
Unspecified Respiratory Problem	7	7
Obstruction/Occlusion	6	6
Cough	6	6
Dyspnea	5	5
Aspiration/Inhalation	5	5
Cancer	4	4
Tachycardia	4	4
Viral Infection	4	4
Pneumonia	4	4
Discomfort	4	4
Respiratory Arrest	3	3
Patient Problem/Medical Problem	3	3
Full thickness (Third Degree) Burn	3	3
Blister	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Respiratory Failure	3	3
No Code Available	2	2
Hypothermia	2	2
Eye Irritation	2	2
Increased Respiratory Rate	2	2
Pain	2	2
Skin Inflammation/ Irritation	2	2
Pressure Sore/Ulcer	2	2
Distress	2	2
Asthma	2	2
Burn, Thermal	2	3
Inflammation	1	1
Epistaxis	1	1
Heart Failure/Congestive Heart Failure	1	1
Fever	1	1
Irritability	1	1
Bacterial Infection	1	1
Choking	1	1
Headache	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Fisher & Paykel Healthcare, Ltd.	II	Oct-15-2025
2	Fisher & Paykel Healthcare, Ltd.	II	May-15-2024
3	Hamilton Medical AG	III	Jul-14-2022
4	TELEFLEX MEDICAL INC	I	Feb-07-2020
5	Vapotherm	II	Mar-17-2023
6	Vyaire Medical	I	Jan-24-2018