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	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
LABORATORIOS BIOGALENIC, S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP.
	SUBSTANTIALLY EQUIVALENT	2
PERMA PURE LLC
	SUBSTANTIALLY EQUIVALENT	1
TELESAIR, 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	1766	1766
Material Split, Cut or Torn	511	511
Break	347	347
Leak/Splash	331	331
Insufficient Heating	300	300
Crack	297	297
Fluid/Blood Leak	284	284
Detachment of Device or Device Component	216	216
Failure to Power Up	181	181
Device Alarm System	101	101
Gas/Air Leak	92	92
Complete Loss of Power	83	83
Melted	81	81
Defective Alarm	79	79
Mechanical Problem	76	76
Power Problem	57	57
Disconnection	51	51
Temperature Problem	48	48
Adverse Event Without Identified Device or Use Problem	42	42
Overfill	34	34
Insufficient Information	30	30
Material Puncture/Hole	29	29
Stretched	28	28
Therapeutic or Diagnostic Output Failure	28	28
No Audible Prompt/Feedback	24	24
Overheating of Device	24	24
Infusion or Flow Problem	20	20
Unexpected Shutdown	17	17
Improper Flow or Infusion	17	17
Obstruction of Flow	17	17
Use of Device Problem	17	17
Device Dislodged or Dislocated	15	15
Output Problem	15	15
Connection Problem	15	15
Misconnection	14	14
Protective Measures Problem	14	14
Moisture or Humidity Problem	13	13
Defective Device	13	13
Contamination /Decontamination Problem	12	12
Difficult to Open or Close	11	11
Unintended Movement	11	11
Improper or Incorrect Procedure or Method	11	11
No Flow	11	11
Failure to Read Input Signal	11	11
Material Integrity Problem	10	10
Sparking	10	10
Device Emits Odor	10	10
Corroded	9	9
Loose or Intermittent Connection	9	9
Fire	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3618	3618
No Patient Involvement	350	350
No Known Impact Or Consequence To Patient	314	314
Low Oxygen Saturation	236	236
Insufficient Information	103	103
No Consequences Or Impact To Patient	87	87
Burn(s)	14	14
Death	12	12
No Information	12	12
Hypoxia	11	11
Cardiac Arrest	9	9
Bradycardia	8	8
Partial thickness (Second Degree) Burn	8	8
Superficial (First Degree) Burn	6	6
Unspecified Respiratory Problem	6	6
Obstruction/Occlusion	5	5
Cancer	5	5
Cough	4	4
Pneumonia	4	4
Airway Obstruction	4	4
Viral Infection	4	4
Tachycardia	3	3
Respiratory Arrest	3	3
Respiratory Failure	3	3
Dyspnea	3	3
Discomfort	3	3
Increased Respiratory Rate	2	2
Pain	2	2
Pressure Sores	2	2
Blister	2	2
Burn, Thermal	2	2
Respiratory Distress	2	2
Full thickness (Third Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	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
Hypothermia	1	1
Respiratory Tract Infection	1	1
Swelling	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