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	8
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	3
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	1815	1815
Material Split, Cut or Torn	544	544
Leak/Splash	364	364
Break	357	357
Crack	336	336
Insufficient Heating	300	300
Fluid/Blood Leak	295	295
Detachment of Device or Device Component	283	283
Failure to Power Up	181	181
Gas/Air Leak	107	107
Device Alarm System	103	103
Melted	89	89
Complete Loss of Power	83	83
Defective Alarm	81	81
Mechanical Problem	79	79
Power Problem	57	57
Disconnection	51	51
Temperature Problem	48	48
Adverse Event Without Identified Device or Use Problem	43	43
Stretched	43	43
Material Puncture/Hole	35	35
Overfill	34	34
Insufficient Information	31	31
Therapeutic or Diagnostic Output Failure	28	28
No Audible Prompt/Feedback	24	24
Overheating of Device	24	24
Infusion or Flow Problem	21	21
Device Dislodged or Dislocated	21	21
Unexpected Shutdown	18	18
Use of Device Problem	18	18
Improper Flow or Infusion	17	17
Obstruction of Flow	17	17
Output Problem	16	16
Connection Problem	16	16
Misconnection	14	14
Moisture or Humidity Problem	14	14
Protective Measures Problem	14	14
Defective Device	13	13
Contamination /Decontamination Problem	12	12
Failure to Read Input Signal	11	11
Loose or Intermittent Connection	11	11
Unintended Movement	11	11
Difficult to Open or Close	11	11
Improper or Incorrect Procedure or Method	11	11
No Flow	11	11
Device Emits Odor	10	10
Sparking	10	10
Material Integrity Problem	10	10
Corroded	9	9
Intermittent Loss of Power	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3842	3842
No Patient Involvement	350	350
No Known Impact Or Consequence To Patient	314	314
Low Oxygen Saturation	257	257
Insufficient Information	107	107
No Consequences Or Impact To Patient	87	87
Burn(s)	14	14
Hypoxia	13	13
Death	12	12
No Information	12	12
Cardiac Arrest	9	9
Bradycardia	8	8
Partial thickness (Second Degree) Burn	8	8
Superficial (First Degree) Burn	7	7
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
Dyspnea	3	3
Discomfort	3	3
Respiratory Arrest	3	3
Respiratory Failure	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Blister	2	2
Pressure Sores	2	2
Burn, Thermal	2	2
Respiratory Distress	2	2
Pain	2	2
Full thickness (Third Degree) Burn	2	2
Increased Respiratory Rate	2	2
Respiratory Insufficiency	1	1
Bacterial Infection	1	1
Fibrosis	1	1
Inadequate Pain Relief	1	1
Irritability	1	1
Hyperventilation	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
Erythema	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