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	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
1. K223863 BONHAWA Respiratory Humidifier
TNI MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
VAPOTHERM, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	3317	3317
Defective Alarm	1673	1675
Material Split, Cut or Torn	605	610
Leak/Splash	474	480
Crack	472	476
Detachment of Device or Device Component	450	461
Break	402	417
Fluid/Blood Leak	378	379
Insufficient Heating	307	307
Failure to Power Up	186	186
Gas/Air Leak	142	142
Device Alarm System	139	139
Melted	111	111
Mechanical Problem	92	93
Complete Loss of Power	83	83
Adverse Event Without Identified Device or Use Problem	68	68
Disconnection	61	63
Power Problem	58	58
Stretched	52	53
Temperature Problem	52	52
Overfill	51	51
Insufficient Information	47	47
Material Puncture/Hole	42	42
Device Dislodged or Dislocated	33	33
Therapeutic or Diagnostic Output Failure	32	34
Overheating of Device	31	32
Use of Device Problem	29	29
Infusion or Flow Problem	27	27
No Audible Prompt/Feedback	27	27
Defective Component	27	27
Obstruction of Flow	25	25
Loose or Intermittent Connection	21	21
Connection Problem	20	21
Unexpected Shutdown	20	20
Moisture or Humidity Problem	20	20
Improper Flow or Infusion	19	19
Device Displays Incorrect Message	18	18
Defective Device	18	18
Output Problem	17	17
No Flow	17	19
Improper or Incorrect Procedure or Method	17	17
Misconnection	17	17
No Apparent Adverse Event	16	16
Protective Measures Problem	15	15
Material Integrity Problem	14	14
Difficult to Open or Close	14	14
Fire	14	14
Unintended Movement	13	13
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Loss of Power	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5871	5905
No Patient Involvement	1279	1279
No Known Impact Or Consequence To Patient	920	922
No Consequences Or Impact To Patient	319	320
Low Oxygen Saturation	315	317
Insufficient Information	118	119
Death	25	25
Hypoxia	19	19
Burn(s)	18	18
No Information	14	14
Partial thickness (Second Degree) Burn	11	11
Bradycardia	11	11
Cardiac Arrest	10	10
Superficial (First Degree) Burn	8	8
Respiratory Distress	7	7
Unspecified Respiratory Problem	7	7
Airway Obstruction	6	6
Cough	6	6
Obstruction/Occlusion	6	6
Aspiration/Inhalation	5	5
Dyspnea	5	5
Cancer	4	4
Tachycardia	4	4
Pneumonia	4	4
Viral Infection	4	4
Discomfort	4	4
Patient Problem/Medical Problem	3	3
Respiratory Failure	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Full thickness (Third Degree) Burn	3	3
Respiratory Arrest	3	3
Blister	3	3
Distress	2	2
Pressure Sores	2	2
Increased Respiratory Rate	2	2
Pain	2	2
Burn, Thermal	2	3
Asthma	2	2
No Code Available	2	2
Skin Inflammation/ Irritation	2	2
Bronchitis	1	1
Unspecified Infection	1	1
Decreased Respiratory Rate	1	1
Ventilator Dependent	1	1
Sleep Dysfunction	1	1
Low Blood Pressure/ Hypotension	1	1
Cyanosis	1	1
Electric Shock	1	1
Complaint, Ill-Defined	1	1
Irritability	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