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	7
FISHER & PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
FISHER &PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOMETA INC
	SUBSTANTIALLY EQUIVALENT	1
INVENT MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LABORATORIOS BIOGALENIC, S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	1
1. K242717 Laboratorios Biogalenic Sterile Water for Inhalati ...
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP.
	SUBSTANTIALLY EQUIVALENT	2
PERMA PURE LLC
	SUBSTANTIALLY EQUIVALENT	1
TELESAIR, INC.
	SUBSTANTIALLY EQUIVALENT	1
TNI MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
VAPOTHERM 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	3199	3199
Material Split, Cut or Torn	517	517
Leak/Splash	408	408
Crack	390	390
Break	360	360
Fluid/Blood Leak	314	314
Insufficient Heating	307	307
Detachment of Device or Device Component	219	219
Failure to Power Up	186	186
Device Alarm System	135	135
Gas/Air Leak	100	100
Melted	87	87
Complete Loss of Power	83	83
Defective Alarm	82	82
Mechanical Problem	78	78
Adverse Event Without Identified Device or Use Problem	62	62
Disconnection	59	59
Power Problem	58	58
Temperature Problem	51	51
Overfill	51	51
Insufficient Information	36	36
Therapeutic or Diagnostic Output Failure	32	32
Material Puncture/Hole	32	32
Overheating of Device	30	30
Stretched	28	28
Use of Device Problem	27	27
No Audible Prompt/Feedback	27	27
Infusion or Flow Problem	26	26
Defective Component	26	26
Obstruction of Flow	25	25
Improper Flow or Infusion	19	19
Unexpected Shutdown	19	19
Device Displays Incorrect Message	18	18
Defective Device	18	18
Moisture or Humidity Problem	17	17
Connection Problem	17	17
Improper or Incorrect Procedure or Method	17	17
No Apparent Adverse Event	16	16
Misconnection	16	16
No Flow	16	16
Output Problem	16	16
Device Dislodged or Dislocated	15	15
Protective Measures Problem	15	15
Difficult to Open or Close	14	14
Loose or Intermittent Connection	13	13
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Fire	13	13
Unintended Movement	12	12
Material Integrity Problem	12	12
Failure to Deliver	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3618	3618
No Patient Involvement	1279	1279
No Known Impact Or Consequence To Patient	920	920
No Consequences Or Impact To Patient	319	319
Low Oxygen Saturation	261	261
Insufficient Information	103	103
Death	25	25
Burn(s)	16	16
No Information	14	14
Hypoxia	14	14
Partial thickness (Second Degree) Burn	10	10
Bradycardia	9	9
Cardiac Arrest	9	9
Respiratory Distress	7	7
Superficial (First Degree) Burn	6	6
Unspecified Respiratory Problem	6	6
Obstruction/Occlusion	6	6
Cancer	5	5
Airway Obstruction	4	4
Cough	4	4
Tachycardia	4	4
Pneumonia	4	4
Dyspnea	4	4
Viral Infection	4	4
Patient Problem/Medical Problem	3	3
Full thickness (Third Degree) Burn	3	3
Respiratory Failure	3	3
Respiratory Arrest	3	3
Aspiration/Inhalation	3	3
Discomfort	3	3
Distress	2	2
Pressure Sores	2	2
Increased Respiratory Rate	2	2
Pain	2	2
Blister	2	2
Burn, Thermal	2	2
Asthma	2	2
No Code Available	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Burning Sensation	1	1
Skin Erosion	1	1
Fever	1	1
Epistaxis	1	1
Erythema	1	1
Swelling	1	1
Respiratory Tract Infection	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Neurological Deficit/Dysfunction	1	1
Hypothermia	1	1
Unspecified Kidney or Urinary Problem	1	1

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