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
1.  K231064  ReddyPort Elbow

MDR Year	MDR Reports	MDR Events
2019	275	275
2020	64	64
2021	254	254
2022	2499	2499
2023	1314	1314
2024	492	492

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	4053	4053
Corroded	233	233
Contamination	72	72
Nonstandard Device	46	46
Adverse Event Without Identified Device or Use Problem	46	46
Device Displays Incorrect Message	42	42
Battery Problem	39	39
Failure to Power Up	35	35
Electrical /Electronic Property Problem	34	34
Unexpected Shutdown	28	28
Power Problem	26	26
Output Problem	26	26
Pressure Problem	24	24
Device Alarm System	23	23
Patient-Device Incompatibility	20	20
Therapeutic or Diagnostic Output Failure	20	20
Insufficient Information	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
Break	6	6
Defective Alarm	6	6
Crack	6	6
Fire	5	5
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	2712	2712
Dyspnea	559	559
Headache	434	434
Unspecified Respiratory Problem	396	396
Cough	239	239
Sore Throat	232	232
Dizziness	216	216
Respiratory Tract Infection	189	189
Cancer	184	184
No Patient Involvement	176	176
Asthma	110	110
No Known Impact Or Consequence To Patient	77	77
Nausea	75	75
Unspecified Kidney or Urinary Problem	75	75
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	75	75
Insufficient Information	72	72
Unspecified Heart Problem	70	70
Dry Mouth	67	67
Skin Inflammation/ Irritation	58	58
No Consequences Or Impact To Patient	53	53
Inflammation	49	49
Chest Pain	48	48
Vomiting	42	42
Sleep Dysfunction	41	41
Hypersensitivity/Allergic reaction	41	41
Epistaxis	35	35
Stroke/CVA	29	29
Chronic Obstructive Pulmonary Disease (COPD)	29	29
Fatigue	28	28
Heart Failure/Congestive Heart Failure	25	25
Pneumonia	24	24
Apnea	22	22
Nodule	21	21
Unspecified Hepatic or Biliary Problem	20	20
Liver Damage/Dysfunction	20	20
Pharyngitis	17	17
Pain	16	16
Cardiac Arrest	15	15
Unspecified Eye / Vision Problem	15	15
Dry Eye(s)	14	14
Pulmonary Dysfunction	14	14
Atrial Fibrillation	13	13
Respiratory Failure	13	13
Sneezing	13	13
Rash	12	12
Renal Failure	12	12
Low Oxygen Saturation	12	12
Bronchitis	12	12
Unspecified Infection	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
Burning Sensation	8	8
Myocardial Infarction	7	7
Choking	7	7
Arrhythmia	7	7
Pulmonary Emphysema	7	7
Unspecified Ear or Labyrinth Problem	7	7
Pulmonary Hypertension	6	6
Solid Tumour	6	6
Abdominal Pain	6	6
Hemoptysis	6	6
Memory Loss/Impairment	6	6
Nasal Obstruction	6	6
Confusion/ Disorientation	6	6
Lethargy	6	6
Weight Changes	6	6
Anxiety	6	6
Discomfort	6	6
Fever	5	5
Death	5	5
Breast Cancer	5	5
Skin Disorders	5	5
Respiratory Insufficiency	5	5
Wheezing	5	5
Cardiovascular Insufficiency	5	5
Unspecified Mental, Emotional or Behavioural Problem	4	4
Eye Infections	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
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
Balance Problems	3	3
Convulsion/Seizure	2	2
Constipation	2	2
Partial Hearing Loss	2	2
Gastroesophageal Burn	2	2
Liver Failure	2	2
Cramp(s) /Muscle Spasm(s)	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