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	8
FISHER & PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
FISHER &PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOMETA INC
	SUBSTANTIALLY EQUIVALENT	1
1. K223551 Sterile Water for Inhalation in 1L Flexoval ® bott ...
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
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	3285	3285
Material Split, Cut or Torn	580	581
Leak/Splash	465	467
Crack	449	449
Break	396	396
Detachment of Device or Device Component	369	370
Fluid/Blood Leak	356	356
Insufficient Heating	307	307
Defective Alarm	248	248
Failure to Power Up	186	186
Device Alarm System	138	138
Gas/Air Leak	125	125
Melted	99	99
Mechanical Problem	87	87
Complete Loss of Power	83	83
Adverse Event Without Identified Device or Use Problem	65	65
Disconnection	60	60
Power Problem	58	58
Stretched	51	52
Overfill	51	51
Temperature Problem	51	51
Insufficient Information	45	45
Material Puncture/Hole	41	41
Therapeutic or Diagnostic Output Failure	32	34
Overheating of Device	31	32
Use of Device Problem	29	29
Device Dislodged or Dislocated	29	29
Infusion or Flow Problem	27	27
Defective Component	27	27
No Audible Prompt/Feedback	27	27
Obstruction of Flow	25	25
Unexpected Shutdown	20	20
Loose or Intermittent Connection	20	20
Connection Problem	19	19
Improper Flow or Infusion	19	19
Moisture or Humidity Problem	18	18
Device Displays Incorrect Message	18	18
Defective Device	18	18
Output Problem	17	17
Improper or Incorrect Procedure or Method	17	17
No Apparent Adverse Event	16	16
No Flow	16	18
Misconnection	16	16
Protective Measures Problem	15	15
Difficult to Open or Close	14	14
Fire	14	14
Unintended Movement	13	13
Material Integrity Problem	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	4256	4258
No Patient Involvement	1279	1279
No Known Impact Or Consequence To Patient	920	922
No Consequences Or Impact To Patient	319	319
Low Oxygen Saturation	297	297
Insufficient Information	111	111
Death	25	25
Hypoxia	19	19
Burn(s)	16	16
No Information	14	14
Partial thickness (Second Degree) Burn	10	10
Bradycardia	10	10
Cardiac Arrest	10	10
Superficial (First Degree) Burn	7	7
Respiratory Distress	7	7
Unspecified Respiratory Problem	6	6
Obstruction/Occlusion	6	6
Cancer	5	5
Cough	5	5
Dyspnea	5	5
Airway Obstruction	4	4
Aspiration/Inhalation	4	4
Tachycardia	4	4
Pneumonia	4	4
Discomfort	4	4
Viral Infection	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
Distress	2	2
Pressure Sores	2	2
Increased Respiratory Rate	2	2
Pain	2	2
Blister	2	2
Burn, Thermal	2	3
Asthma	2	2
Skin Inflammation/ Irritation	2	2
No Code Available	2	2
Bronchitis	1	1
Cyanosis	1	1
Decreased Respiratory Rate	1	1
Ventilator Dependent	1	1
Low Blood Pressure/ Hypotension	1	1
Unspecified Infection	1	1
Sleep Dysfunction	1	1
Arrhythmia	1	1
Stroke/CVA	1	1
Respiratory Insufficiency	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