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 HEALTH CARE
	SUBSTANTIALLY EQUIVALENT	2
FISHER &PAYKEL HEALTHCARE , LTD.
	SUBSTANTIALLY EQUIVALENT	10
HOMETA, INC.
	SUBSTANTIALLY EQUIVALENT	1
INVENT MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LABORATORIOS BIOGALENIC S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	3
PERMA PURE, LLC
	SUBSTANTIALLY EQUIVALENT	1
TELESAIR, INC.
	SUBSTANTIALLY EQUIVALENT	1
VAPOTHERM, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	1860	1860
Defective Alarm	669	671
Material Split, Cut or Torn	582	587
Leak/Splash	389	395
Break	384	399
Detachment of Device or Device Component	379	390
Crack	363	367
Fluid/Blood Leak	329	330
Insufficient Heating	300	300
Failure to Power Up	181	181
Gas/Air Leak	121	121
Device Alarm System	104	104
Melted	95	95
Mechanical Problem	85	86
Complete Loss of Power	83	83
Power Problem	57	57
Disconnection	53	55
Stretched	51	52
Temperature Problem	48	48
Adverse Event Without Identified Device or Use Problem	44	44
Insufficient Information	40	40
Material Puncture/Hole	38	38
Overfill	34	34
Device Dislodged or Dislocated	29	29
Therapeutic or Diagnostic Output Failure	28	30
Overheating of Device	25	26
No Audible Prompt/Feedback	24	24
Infusion or Flow Problem	21	21
Use of Device Problem	19	19
Unexpected Shutdown	18	18
Improper Flow or Infusion	17	17
Obstruction of Flow	17	17
Connection Problem	17	18
Loose or Intermittent Connection	16	16
Output Problem	16	16
Misconnection	15	15
Moisture or Humidity Problem	14	14
Protective Measures Problem	14	14
Defective Device	13	13
Contamination /Decontamination Problem	12	12
Material Integrity Problem	12	12
Unintended Movement	12	12
Difficult to Open or Close	11	11
Improper or Incorrect Procedure or Method	11	11
No Flow	11	13
Sparking	11	11
Failure to Read Input Signal	11	11
Device Emits Odor	10	10
Fire	10	10
Defective Component	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4729	4763
No Patient Involvement	350	350
No Known Impact Or Consequence To Patient	314	316
Low Oxygen Saturation	275	277
Insufficient Information	115	116
No Consequences Or Impact To Patient	87	88
Hypoxia	16	16
Burn(s)	14	14
Death	12	12
No Information	12	12
Cardiac Arrest	10	10
Bradycardia	9	9
Partial thickness (Second Degree) Burn	8	8
Superficial (First Degree) Burn	7	7
Unspecified Respiratory Problem	6	6
Cough	5	5
Obstruction/Occlusion	5	5
Airway Obstruction	4	4
Cancer	4	4
Pneumonia	4	4
Dyspnea	4	4
Viral Infection	4	4
Discomfort	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Respiratory Failure	3	3
Respiratory Arrest	3	3
Tachycardia	3	3
Full thickness (Third Degree) Burn	2	2
Pressure Sores	2	2
Increased Respiratory Rate	2	2
Pain	2	2
Blister	2	2
Burn, Thermal	2	3
Aspiration/Inhalation	2	2
Skin Inflammation/ Irritation	2	2
Respiratory Distress	2	2
Burning Sensation	1	1
Fever	1	1
Chest Pain	1	1
Erythema	1	1
Swelling	1	1
Respiratory Tract Infection	1	1
Epistaxis	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Hypothermia	1	1
Unspecified Kidney or Urinary Problem	1	1
Asthma	1	1
Nasal Obstruction	1	1
Heart Failure/Congestive Heart Failure	1	1
Inflammation	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