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
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	3353	3353
Defective Alarm	2425	2428
Material Split, Cut or Torn	639	644
Detachment of Device or Device Component	494	505
Leak/Splash	482	488
Crack	480	484
Break	411	426
Fluid/Blood Leak	389	390
Insufficient Heating	309	309
Failure to Power Up	186	186
Gas/Air Leak	150	150
Device Alarm System	139	139
Melted	122	122
Mechanical Problem	96	97
Complete Loss of Power	83	83
Adverse Event Without Identified Device or Use Problem	69	69
Disconnection	61	63
Power Problem	58	58
Stretched	54	55
Temperature Problem	52	52
Overfill	51	51
Insufficient Information	49	49
Material Puncture/Hole	45	45
Device Dislodged or Dislocated	34	34
Therapeutic or Diagnostic Output Failure	32	34
Overheating of Device	31	32
Use of Device Problem	29	29
Infusion or Flow Problem	27	27
Defective Component	27	27
No Audible Prompt/Feedback	27	27
Obstruction of Flow	25	25
Loose or Intermittent Connection	22	22
Connection Problem	21	22
Unexpected Shutdown	20	20
Moisture or Humidity Problem	20	20
Improper Flow or Infusion	19	19
Misconnection	18	18
Defective Device	18	18
Material Integrity Problem	18	18
Device Displays Incorrect Message	18	18
Output Problem	17	17
Improper or Incorrect Procedure or Method	17	17
No Flow	17	19
No Apparent Adverse Event	16	16
Protective Measures Problem	15	15
Fire	15	15
Appropriate Term/Code Not Available	14	14
Difficult to Open or Close	14	14
Unintended Movement	13	13
Incorrect, Inadequate or Imprecise Result or Readings	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6776	6811
No Patient Involvement	1279	1279
No Known Impact Or Consequence To Patient	920	922
Low Oxygen Saturation	331	333
No Consequences Or Impact To Patient	319	320
Insufficient Information	124	125
Death	25	25
Hypoxia	19	19
Burn(s)	18	18
No Information	14	14
Bradycardia	11	11
Partial thickness (Second Degree) Burn	11	11
Cardiac Arrest	10	10
Superficial (First Degree) Burn	8	8
Respiratory Distress	7	7
Airway Obstruction	7	7
Unspecified Respiratory Problem	7	7
Cough	6	6
Obstruction/Occlusion	6	6
Aspiration/Inhalation	5	5
Dyspnea	5	5
Tachycardia	4	4
Pneumonia	4	4
Discomfort	4	4
Viral Infection	4	4
Cancer	4	4
Patient Problem/Medical Problem	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Full thickness (Third Degree) Burn	3	3
Respiratory Failure	3	3
Respiratory Arrest	3	3
Blister	3	3
Increased Respiratory Rate	2	2
Pain	2	2
Hypothermia	2	2
Pressure Sores	2	2
Burn, Thermal	2	3
Asthma	2	2
Skin Inflammation/ Irritation	2	2
No Code Available	2	2
Distress	2	2
Bacterial Infection	1	1
Headache	1	1
Inadequate Pain Relief	1	1
Irritability	1	1
Myocardial Infarction	1	1
Hyperventilation	1	1
Fibrosis	1	1
Respiratory Insufficiency	1	1
Low Blood Pressure/ Hypotension	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