TPLC - Total Product Life Cycle

• Device: ventilator, continuous, non-life-supporting
• Product Code: MNS
• Regulation Number: 868.5895
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BMC MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMD MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	275	275
2020	64	64
2021	254	254
2022	2499	2499
2023	1314	1314
2024	623	623

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	4176	4176
Corroded	233	233
Contamination	72	72
Adverse Event Without Identified Device or Use Problem	51	51
Nonstandard Device	46	46
Device Displays Incorrect Message	42	42
Battery Problem	39	39
Electrical /Electronic Property Problem	36	36
Failure to Power Up	35	35
Unexpected Shutdown	29	29
Power Problem	26	26
Output Problem	26	26
Pressure Problem	24	24
Device Alarm System	23	23
Patient-Device Incompatibility	20	20
Insufficient Information	20	20
Therapeutic or Diagnostic Output Failure	20	20
Circuit Failure	19	19
Protective Measures Problem	17	17
Increase in Pressure	15	15
Device Emits Odor	14	14
Defective Component	13	13
Defective Device	11	11
Failure to Charge	11	11
Material Integrity Problem	11	11
Noise, Audible	11	11
Mechanical Problem	10	10
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Self-Activation or Keying	9	9
Display or Visual Feedback Problem	9	9
Failure to Calibrate	9	9
Overheating of Device	7	7
Decrease in Pressure	7	7
Loss of Power	6	6
Fire	6	6
Break	6	6
Defective Alarm	6	6
Crack	6	6
Component Missing	5	5
Temperature Problem	5	5
Inadequate User Interface	4	4
Contamination /Decontamination Problem	4	4
Communication or Transmission Problem	4	4
Computer Operating System Problem	4	4
Calibration Problem	4	4
Patient Device Interaction Problem	4	4
Computer Software Problem	4	4
Thermal Decomposition of Device	3	3
No Audible Alarm	3	3
Unintended Power Up	3	3
Melted	3	3
No Display/Image	3	3
Failure to Run on Battery	3	3
Complete Loss of Power	3	3
Excessive Heating	3	3
Failure to Shut Off	3	3
Device Contamination with Chemical or Other Material	3	3
Device Sensing Problem	3	3
No Pressure	3	3
Improper Flow or Infusion	3	3
Detachment of Device or Device Component	2	2
Charging Problem	2	2
Electrical Shorting	2	2
Unintended Application Program Shut Down	2	2
Appropriate Term/Code Not Available	2	2
Failure to Sense	2	2
Smoking	2	2
Tidal Volume Fluctuations	2	2
Inaccurate Delivery	2	2
Leak/Splash	2	2
Loose or Intermittent Connection	2	2
Moisture Damage	2	2
Material Fragmentation	2	2
Intermittent Continuity	2	2
Material Disintegration	2	2
Display Difficult to Read	1	1
Insufficient Cooling	1	1
Insufficient Heating	1	1
Image Display Error/Artifact	1	1
Excess Flow or Over-Infusion	1	1
Poor Quality Image	1	1
Disconnection	1	1
Failure to Disinfect	1	1
Failure to Cycle	1	1
Decrease in Suction	1	1
Loss of or Failure to Bond	1	1
Dent in Material	1	1
Application Security Problem	1	1
Blocked Connection	1	1
Unstable	1	1
Use of Device Problem	1	1
Fitting Problem	1	1
Inaccurate Synchronization	1	1
Fungus in Device Environment	1	1
Material Separation	1	1
Product Quality Problem	1	1
Failure to Transmit Record	1	1
Premature End-of-Life Indicator	1	1
Pacing Problem	1	1
Particulates	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2742	2742
Dyspnea	561	561
Headache	464	464
Unspecified Respiratory Problem	447	447
Dizziness	245	245
Cough	239	239
Sore Throat	232	232
Cancer	220	220
Respiratory Tract Infection	196	196
No Patient Involvement	176	176
Asthma	130	130
Unspecified Kidney or Urinary Problem	93	93
Nausea	88	88
Unspecified Heart Problem	84	84
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	77	77
No Known Impact Or Consequence To Patient	77	77
Skin Inflammation/ Irritation	75	75
Insufficient Information	74	74
Dry Mouth	67	67
Inflammation	66	66
No Consequences Or Impact To Patient	53	53
Vomiting	53	53
Hypersensitivity/Allergic reaction	52	52
Chest Pain	48	48
Sleep Dysfunction	41	41
Epistaxis	35	35
Chronic Obstructive Pulmonary Disease (COPD)	31	31
Stroke/CVA	30	30
Fatigue	28	28
Heart Failure/Congestive Heart Failure	28	28
Unspecified Hepatic or Biliary Problem	26	26
Pneumonia	25	25
Apnea	22	22
Liver Damage/Dysfunction	21	21
Nodule	21	21
Pharyngitis	17	17
Pain	16	16
Cardiac Arrest	15	15
Unspecified Eye / Vision Problem	15	15
Dry Eye(s)	14	14
Atrial Fibrillation	14	14
Pulmonary Dysfunction	14	14
Sneezing	13	13
Renal Failure	13	13
Respiratory Failure	13	13
Low Oxygen Saturation	12	12
Rash	12	12
Unspecified Infection	12	12
Bronchitis	12	12
Unspecified Gastrointestinal Problem	11	11
Swelling/ Edema	11	11
Renal Impairment	10	10
Eye Pain	9	9
High Blood Pressure/ Hypertension	9	9
Angina	8	8
Pulmonary Emphysema	8	8
Burning Sensation	8	8
Myocardial Infarction	7	7
Choking	7	7
Arrhythmia	7	7
Unspecified Ear or Labyrinth Problem	7	7
Cardiovascular Insufficiency	7	7
Pulmonary Hypertension	6	6
Solid Tumour	6	6
Skin Disorders	6	6
Abdominal Pain	6	6
Hemoptysis	6	6
Memory Loss/Impairment	6	6
Nasal Obstruction	6	6
Weight Changes	6	6
Confusion/ Disorientation	6	6
Lethargy	6	6
Anxiety	6	6
Discomfort	6	6
Fever	5	5
Death	5	5
Breast Cancer	5	5
Respiratory Insufficiency	5	5
Wheezing	5	5
Eye Infections	4	4
Unspecified Mental, Emotional or Behavioural Problem	4	4
Bacterial Infection	4	4
Hemorrhage/Bleeding	4	4
Hypoxia	4	4
Malaise	4	4
Red Eye(s)	4	4
Cognitive Changes	4	4
Balance Problems	3	3
Neck Pain	3	3
Tachycardia	3	3
Tinnitus	3	3
Loss of Vision	3	3
Overinflation of Lung	3	3
Unspecified Blood or Lymphatic problem	3	3
Blister	3	3
Skin Burning Sensation	2	2
Unspecified Reproductive System or Breast Problem	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Unspecified Immune System Problem	2	2
Syncope/Fainting	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Philips Respironics, Inc.	I	May-24-2024
2	Philips Respironics, Inc.	I	May-23-2024
3	Philips Respironics, Inc.	I	Sep-09-2022
4	Philips Respironics, Inc.	I	Jul-15-2021
5	Philips Respironics, Inc.	I	Jul-13-2021
6	Philips Respironics, Inc.	II	May-21-2021