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	3
FISHER & PAYKEL HEALTHCARE LTD
	SUBSTANTIALLY EQUIVALENT	7
FISHER & PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
FISHER &PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K211096 Optiflow Oxygen Kit
HOMETA INC
	SUBSTANTIALLY EQUIVALENT	1
INVENT MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	3143	3143
Material Split, Cut or Torn	455	455
Leak/Splash	403	403
Crack	372	372
Break	339	339
Fluid/Blood Leak	309	309
Insufficient Heating	307	307
Failure to Power Up	186	186
Detachment of Device or Device Component	162	162
Device Alarm System	135	135
Melted	85	85
Complete Loss of Power	83	83
Defective Alarm	81	81
Gas/Air Leak	77	77
Mechanical Problem	64	64
Adverse Event Without Identified Device or Use Problem	61	61
Power Problem	58	58
Disconnection	57	57
Temperature Problem	51	51
Overfill	50	50
Therapeutic or Diagnostic Output Failure	32	32
Overheating of Device	30	30
Material Puncture/Hole	29	29
Insufficient Information	28	28
Use of Device Problem	27	27
No Audible Prompt/Feedback	27	27
Defective Component	26	26
Infusion or Flow Problem	25	25
Obstruction of Flow	25	25
Stretched	20	20
Improper Flow or Infusion	19	19
Unexpected Shutdown	19	19
Device Displays Incorrect Message	18	18
Defective Device	18	18
Improper or Incorrect Procedure or Method	17	17
No Flow	16	16
No Apparent Adverse Event	16	16
Output Problem	16	16
Moisture or Humidity Problem	15	15
Protective Measures Problem	15	15
Misconnection	15	15
Difficult to Open or Close	14	14
Connection Problem	14	14
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Loose or Intermittent Connection	13	13
Fire	13	13
Contamination /Decontamination Problem	12	12
Failure to Deliver	12	12
Unintended Movement	12	12
Loss of Power	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3371	3371
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	236	236
Insufficient Information	97	97
Death	25	25
Burn(s)	15	15
No Information	14	14
Hypoxia	12	12
Bradycardia	9	9
Cardiac Arrest	9	9
Partial thickness (Second Degree) Burn	8	8
Respiratory Distress	7	7
Obstruction/Occlusion	6	6
Superficial (First Degree) Burn	5	5
Pneumonia	4	4
Tachycardia	4	4
Cough	4	4
Dyspnea	4	4
Viral Infection	4	4
Unspecified Respiratory Problem	4	4
Cancer	4	4
Airway Obstruction	4	4
Aspiration/Inhalation	3	3
Discomfort	3	3
Respiratory Arrest	3	3
Full thickness (Third Degree) Burn	3	3
Patient Problem/Medical Problem	3	3
Blister	2	2
Burn, Thermal	2	2
Pressure Sores	2	2
No Code Available	2	2
Increased Respiratory Rate	2	2
Distress	2	2
Inadequate Pain Relief	1	1
Bacterial Infection	1	1
Irritability	1	1
Fibrosis	1	1
Myocardial Infarction	1	1
Hyperventilation	1	1
Respiratory Insufficiency	1	1
Low Blood Pressure/ Hypotension	1	1
Ventilator Dependent	1	1
Respiratory Failure	1	1
Decreased Respiratory Rate	1	1
Nasal Obstruction	1	1
Unspecified Kidney or Urinary Problem	1	1
Pain	1	1
Hypothermia	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