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 HEALTH CARE
	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	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
Defective Alarm	1669	1671
No Audible Alarm	1346	1346
Material Split, Cut or Torn	584	587
Detachment of Device or Device Component	439	449
Break	355	365
Leak/Splash	325	328
Crack	305	309
Fluid/Blood Leak	269	270
Insufficient Heating	171	171
Gas/Air Leak	120	120
Failure to Power Up	99	99
Melted	96	96
Mechanical Problem	84	84
Device Alarm System	79	79
Complete Loss of Power	66	66
Stretched	51	52
Temperature Problem	44	44
Disconnection	38	39
Insufficient Information	37	37
Adverse Event Without Identified Device or Use Problem	36	36
Device Dislodged or Dislocated	32	32
Material Puncture/Hole	29	29
Overfill	27	27
No Audible Prompt/Feedback	24	24
Therapeutic or Diagnostic Output Failure	23	23
Loose or Intermittent Connection	17	17
Connection Problem	17	18
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
Contamination /Decontamination Problem	12	12
Protective Measures Problem	12	12
Material Integrity Problem	12	12
Defective Device	12	12
Unintended Movement	12	12
Improper or Incorrect Procedure or Method	11	11
Misconnection	11	11
Failure to Read Input Signal	11	11
Appropriate Term/Code Not Available	10	10
Use of Device Problem	10	10
Unexpected Shutdown	10	10
Overheating of Device	9	9
Fire	9	9
Sparking	9	9
No Flow	8	8
Insufficient Flow or Under Infusion	8	8
Defective Component	7	7
Failure of Device to Self-Test	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5477	5504
Low Oxygen Saturation	269	271
Insufficient Information	113	114
Hypoxia	13	13
Burn(s)	12	12
Superficial (First Degree) Burn	8	8
Partial thickness (Second Degree) Burn	8	8
Cardiac Arrest	7	7
Bradycardia	7	7
Unspecified Respiratory Problem	7	7
Cough	6	6
Obstruction/Occlusion	4	4
Cancer	4	4
Pneumonia	4	4
Tachycardia	3	3
Discomfort	3	3
Respiratory Failure	3	3
Airway Obstruction	3	3
Aspiration/Inhalation	3	3
Respiratory Arrest	3	3
Blister	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Skin Inflammation/ Irritation	2	2
Dyspnea	2	2
Full thickness (Third Degree) Burn	2	2
Viral Infection	2	2
Distress	1	1
Burning Sensation	1	1
Inadequate Pain Relief	1	1
Ventilator Dependent	1	1
Respiratory Tract Infection	1	1
Irritability	1	1
Fibrosis	1	1
Decreased Respiratory Rate	1	1
Increased Respiratory Rate	1	1
Sleep Dysfunction	1	1
Erythema	1	1
Fever	1	1
Headache	1	1
Hyperventilation	1	1
Low Blood Pressure/ Hypotension	1	1
Bronchitis	1	1
Unspecified Infection	1	1
Pain	1	1
Asthma	1	1
Bacterial Infection	1	1
Arrhythmia	1	1
Stroke/CVA	1	1
Chest Pain	1	1
Cyanosis	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