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	10
FLEXICARE MEDICAL LIMITED.
	SUBSTANTIALLY EQUIVALENT	1
HOMETA, INC.
	SUBSTANTIALLY EQUIVALENT	1
INVENT MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LABORATORIOS BIOGALENIC S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	3
TELESAIR, INC.
	SUBSTANTIALLY EQUIVALENT	1
VAPOTHERM, INC.
	SUBSTANTIALLY EQUIVALENT	2
VINCENT HEALTHCARE PRODUCTS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Alarm	2421	2424
No Audible Alarm	1382	1382
Material Split, Cut or Torn	618	621
Detachment of Device or Device Component	483	493
Break	364	374
Leak/Splash	333	336
Crack	313	317
Fluid/Blood Leak	280	281
Insufficient Heating	173	173
Gas/Air Leak	128	128
Melted	107	107
Failure to Power Up	99	99
Mechanical Problem	88	88
Device Alarm System	79	79
Complete Loss of Power	66	66
Stretched	53	54
Temperature Problem	44	44
Insufficient Information	39	39
Disconnection	38	39
Adverse Event Without Identified Device or Use Problem	37	37
Device Dislodged or Dislocated	33	33
Material Puncture/Hole	32	32
Overfill	27	27
No Audible Prompt/Feedback	24	24
Therapeutic or Diagnostic Output Failure	23	23
Loose or Intermittent Connection	18	18
Connection Problem	18	19
Material Integrity Problem	16	16
Infusion or Flow Problem	15	15
Output Problem	14	14
Obstruction of Flow	13	13
Power Problem	13	13
Moisture or Humidity Problem	12	12
Misconnection	12	12
Contamination /Decontamination Problem	12	12
Protective Measures Problem	12	12
Appropriate Term/Code Not Available	12	12
Defective Device	12	12
Unintended Movement	12	12
Improper or Incorrect Procedure or Method	11	11
Sparking	11	11
Failure to Read Input Signal	11	11
Fire	10	10
Use of Device Problem	10	10
Unexpected Shutdown	10	10
Overheating of Device	9	9
Intermittent Loss of Power	9	9
No Flow	8	8
Insufficient Flow or Under Infusion	8	8
Defective Component	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6382	6410
Low Oxygen Saturation	285	287
Insufficient Information	119	120
Hypoxia	13	13
Burn(s)	12	12
Superficial (First Degree) Burn	8	8
Partial thickness (Second Degree) Burn	8	8
Unspecified Respiratory Problem	7	7
Bradycardia	7	7
Cardiac Arrest	7	7
Cough	6	6
Airway Obstruction	4	4
Cancer	4	4
Pneumonia	4	4
Obstruction/Occlusion	4	4
Respiratory Failure	3	3
Tachycardia	3	3
Discomfort	3	3
Blister	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Aspiration/Inhalation	3	3
Respiratory Arrest	3	3
Viral Infection	2	2
Full thickness (Third Degree) Burn	2	2
Dyspnea	2	2
Skin Inflammation/ Irritation	2	2
Distress	1	1
Bronchitis	1	1
Decreased Respiratory Rate	1	1
Ventilator Dependent	1	1
Low Blood Pressure/ Hypotension	1	1
Cyanosis	1	1
Unspecified Infection	1	1
Respiratory Insufficiency	1	1
Fibrosis	1	1
Irritability	1	1
Inadequate Pain Relief	1	1
Headache	1	1
Bacterial Infection	1	1
Sleep Dysfunction	1	1
Hyperventilation	1	1
Arrhythmia	1	1
Stroke/CVA	1	1
Death	1	1
Increased Respiratory Rate	1	1
Wheezing	1	1
Heart Failure/Congestive Heart Failure	1	1
Nasal Obstruction	1	1
Unspecified Kidney or Urinary Problem	1	1
Choking	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	Vapotherm	II	Mar-17-2023