TPLC - Total Product Life Cycle

• 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	2
FISHER & PAYKEL HEALTHCARE LTD
	SUBSTANTIALLY EQUIVALENT	5
FISHER & PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
FISHER &PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOMETA INC
	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

MDR Year	MDR Reports	MDR Events
2018	918	918
2019	894	894
2020	1188	1188
2021	1508	1508
2022	749	749
2023	704	704
2024	117	117

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Audible Alarm	3080	3080
Material Split, Cut or Torn	426	426
Leak/Splash	360	360
Crack	355	355
Break	333	333
Insufficient Heating	307	307
Fluid/Blood Leak	289	289
Failure to Power Up	186	186
Detachment of Device or Device Component	146	146
Device Alarm System	133	133
Complete Loss of Power	83	83
Melted	75	75
Defective Alarm	74	74
Gas/Air Leak	73	73
Mechanical Problem	60	60
Adverse Event Without Identified Device or Use Problem	58	58
Power Problem	58	58
Disconnection	57	57
Temperature Problem	51	51
Overfill	48	48
Therapeutic or Diagnostic Output Failure	32	32
Overheating of Device	30	30
Material Puncture/Hole	29	29
Use of Device Problem	27	27
No Audible Prompt/Feedback	27	27
Insufficient Information	26	26
Defective Component	26	26
Infusion or Flow Problem	25	25
Obstruction of Flow	24	24
Unexpected Shutdown	19	19
Improper Flow or Infusion	19	19
Stretched	19	19
Defective Device	18	18
Device Displays Incorrect Message	18	18
Improper or Incorrect Procedure or Method	17	17
Output Problem	16	16
No Apparent Adverse Event	16	16
Protective Measures Problem	15	15
No Flow	15	15
Misconnection	15	15
Moisture or Humidity Problem	14	14
Difficult to Open or Close	14	14
Connection Problem	14	14
Loose or Intermittent Connection	13	13
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Loss of Power	12	12
Fire	12	12
Contamination /Decontamination Problem	12	12
Failure to Deliver	12	12
Material Integrity Problem	11	11
Unintended Movement	11	11
Device Emits Odor	11	11
Failure to Read Input Signal	11	11
Device Handling Problem	10	10
Device Sensing Problem	10	10
Failure of Device to Self-Test	9	9
Intermittent Loss of Power	9	9
Noise, Audible	8	8
Sparking	8	8
False Alarm	8	8
Corroded	7	7
Display or Visual Feedback Problem	7	7
Filling Problem	7	7
Smoking	7	7
Failure to Sense	6	6
Inaudible or Unclear Audible Prompt/Feedback	6	6
Degraded	6	6
Component Missing	6	6
Excessive Heating	6	6
Device Issue	5	5
Material Deformation	5	5
Electrical /Electronic Property Problem	5	5
Thermal Decomposition of Device	5	5
Fitting Problem	5	5
Failure to Select Signal	5	5
Device Slipped	4	4
Material Separation	4	4
Device Damaged Prior to Use	4	4
Ambient Temperature Problem	4	4
Human-Device Interface Problem	3	3
Device Operates Differently Than Expected	3	3
Material Twisted/Bent	3	3
Audible Prompt/Feedback Problem	3	3
Appropriate Term/Code Not Available	3	3
Physical Resistance/Sticking	3	3
No Device Output	3	3
Incorrect Measurement	3	3
Loss of or Failure to Bond	3	3
Complete Blockage	3	3
Burst Container or Vessel	2	2
Low Audible Alarm	2	2
Air Leak	2	2
Partial Blockage	2	2
Unintended Ejection	2	2
Inaccurate Flow Rate	2	2
Hole In Material	2	2
No Display/Image	2	2
Product Quality Problem	2	2
Failure to Reset	2	2
Inappropriate Audible Prompt/Feedback	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3175	3175
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	224	224
Insufficient Information	90	90
Death	25	25
Burn(s)	15	15
No Information	14	14
Hypoxia	9	9
Bradycardia	9	9
Cardiac Arrest	8	8
Respiratory Distress	7	7
Partial thickness (Second Degree) Burn	7	7
Obstruction/Occlusion	6	6
Superficial (First Degree) Burn	5	5
Pneumonia	4	4
Unspecified Respiratory Problem	4	4
Cough	4	4
Viral Infection	4	4
Tachycardia	4	4
Airway Obstruction	4	4
Dyspnea	4	4
Aspiration/Inhalation	3	3
Discomfort	3	3
Respiratory Arrest	3	3
Cancer	3	3
Full thickness (Third Degree) Burn	3	3
Patient Problem/Medical Problem	3	3
Increased Respiratory Rate	2	2
Burn, Thermal	2	2
No Code Available	2	2
Pressure Sores	2	2
Distress	1	1
Nasal Obstruction	1	1
Complaint, Ill-Defined	1	1
Inadequate Pain Relief	1	1
Ventilator Dependent	1	1
Virus	1	1
Burning Sensation	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Skin Erosion	1	1
Swelling	1	1
Abrasion	1	1
Asthma	1	1
Bacterial Infection	1	1
Arrhythmia	1	1
Stroke/CVA	1	1
Cyanosis	1	1
Erythema	1	1
Fever	1	1
Hyperventilation	1	1
Low Blood Pressure/ Hypotension	1	1
Hypothermia	1	1
Unspecified Infection	1	1
Inflammation	1	1
Myocardial Infarction	1	1
Neurological Deficit/Dysfunction	1	1
Pain	1	1
Fibrosis	1	1
Electric Shock	1	1
Blood Loss	1	1
Respiratory Failure	1	1
Decreased Respiratory Rate	1	1
Respiratory Insufficiency	1	1
Epistaxis	1	1
Blister	1	1
Skin Inflammation/ Irritation	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hamilton Medical AG	III	Jul-14-2022
2	TELEFLEX MEDICAL INC	I	Feb-07-2020
3	Vapotherm	II	Mar-17-2023
4	Vyaire Medical	I	Jan-24-2018