TPLC - Total Product Life Cycle

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Device	humidifier, respiratory gas, (direct patient interface)
Product Code	BTT
Regulation Number	868.5450
Device Class	2

Premarket Reviews
Manufacturer	Decision
FISHER & PAYKEL HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	2
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
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP.
	SUBSTANTIALLY EQUIVALENT	1
PERMA PURE LLC
	SUBSTANTIALLY EQUIVALENT	1
TELESAIR, INC.
	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	2406	2406
Material Split, Cut or Torn	466	466
Leak/Splash	368	368
Break	342	342
Crack	337	337
Insufficient Heating	304	304
Fluid/Blood Leak	302	302
Failure to Power Up	184	184
Detachment of Device or Device Component	175	175
Device Alarm System	129	129
Complete Loss of Power	83	83
Defective Alarm	80	80
Melted	80	80
Gas/Air Leak	78	78
Mechanical Problem	64	64
Power Problem	57	57
Disconnection	52	52
Adverse Event Without Identified Device or Use Problem	51	51
Temperature Problem	48	48
Overfill	45	45
Therapeutic or Diagnostic Output Failure	32	32
Overheating of Device	28	28
Material Puncture/Hole	28	28
Insufficient Information	27	27
No Audible Prompt/Feedback	26	26
Use of Device Problem	25	25
Infusion or Flow Problem	24	24
Obstruction of Flow	23	23
Defective Component	23	23
Stretched	21	21
Unexpected Shutdown	19	19
Improper Flow or Infusion	18	18
Output Problem	16	16
Improper or Incorrect Procedure or Method	16	16
Misconnection	15	15
Protective Measures Problem	15	15
No Flow	14	14
Difficult to Open or Close	14	14
Defective Device	14	14
Connection Problem	14	14
Device Displays Incorrect Message	13	13
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Loose or Intermittent Connection	13	13
Contamination /Decontamination Problem	12	12
Moisture or Humidity Problem	12	12
Unintended Movement	12	12
Failure to Read Input Signal	11	11
Device Emits Odor	11	11
Loss of Power	10	10
Fire	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3399	3399
No Patient Involvement	801	801
No Known Impact Or Consequence To Patient	657	657
Low Oxygen Saturation	223	223
No Consequences Or Impact To Patient	176	176
Insufficient Information	99	99
Death	19	19
Burn(s)	13	13
No Information	12	12
Hypoxia	10	10
Bradycardia	9	9
Cardiac Arrest	9	9
Partial thickness (Second Degree) Burn	7	7
Unspecified Respiratory Problem	6	6
Superficial (First Degree) Burn	5	5
Respiratory Distress	5	5
Obstruction/Occlusion	5	5
Cancer	5	5
Tachycardia	4	4
Cough	4	4
Pneumonia	4	4
Airway Obstruction	4	4
Dyspnea	4	4
Viral Infection	4	4
Patient Problem/Medical Problem	3	3
Full thickness (Third Degree) Burn	3	3
Respiratory Arrest	3	3
Aspiration/Inhalation	3	3
Discomfort	3	3
Increased Respiratory Rate	2	2
Pain	2	2
Pressure Sores	2	2
Blister	2	2
Burn, Thermal	2	2
Asthma	2	2
No Code Available	2	2
Respiratory Failure	2	2
Bacterial Infection	1	1
Inadequate Pain Relief	1	1
Irritability	1	1
Fibrosis	1	1
Hyperventilation	1	1
Respiratory Insufficiency	1	1
Low Blood Pressure/ Hypotension	1	1
Ventilator Dependent	1	1
Decreased Respiratory Rate	1	1
Distress	1	1
Heart Failure/Congestive Heart Failure	1	1
Nasal Obstruction	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