TPLC - Total Product Life Cycle

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Device	ventilator, continuous, non-life-supporting
Regulation Description	Continuous ventilator.
Product Code	MNS
Regulation Number	868.5895
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	8208	8349
Electrical /Electronic Property Problem	844	844
Circuit Failure	569	569
Contamination	386	388
Adverse Event Without Identified Device or Use Problem	276	278
Corroded	233	233
Unexpected Shutdown	65	65
Nonstandard Device	48	60
Overheating of Device	40	40
Device Sensing Problem	27	27
Failure to Power Up	26	26
No Apparent Adverse Event	24	24
Contamination /Decontamination Problem	22	22
Power Problem	21	21
Insufficient Information	21	21
Patient-Device Incompatibility	21	25
Thermal Decomposition of Device	20	20
Device Emits Odor	20	21
Material Integrity Problem	19	19
Mechanical Problem	16	16
Noise, Audible	16	16
Increase in Pressure	10	10
No Display/Image	9	9
Battery Problem	8	8
Patient Device Interaction Problem	7	7
Complete Loss of Power	6	6
Device Alarm System	6	6
Activation Problem	6	7
Excessive Heating	6	6
Therapeutic or Diagnostic Output Failure	6	6
Fire	6	6
Pressure Problem	6	6
Computer Software Problem	5	6
Defective Alarm	5	5
Device Contamination with Chemical or Other Material	5	5
Temperature Problem	5	5
Crack	4	4
Smoking	4	4
Failure to Run on Battery	4	4
Decrease in Pressure	4	4
Material Disintegration	3	3
Break	3	3
Display or Visual Feedback Problem	2	2
Failure to Calibrate	2	2
Ambient Noise Problem	2	2
No Device Output	2	2
Inadequate User Interface	2	2
Insufficient Flow or Under Infusion	2	2
Particulates	2	2
Excess Flow or Over-Infusion	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7103	7194
Unspecified Respiratory Problem	769	785
Headache	642	658
Dyspnea	612	632
Cancer	420	425
Dizziness	402	404
Insufficient Information	290	294
Cough	262	273
Sore Throat	252	257
Asthma	235	239
Unspecified Kidney or Urinary Problem	219	220
Respiratory Tract Infection	216	225
Nausea	156	156
Skin Inflammation/ Irritation	151	151
Inflammation	148	154
Unspecified Heart Problem	125	127
Vomiting	113	113
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	109	110
Hypersensitivity/Allergic reaction	100	101
Unspecified Hepatic or Biliary Problem	74	74
Dry Mouth	71	74
Chronic Obstructive Pulmonary Disease (COPD)	61	62
Chest Pain	57	59
Sleep Dysfunction	47	55
Heart Failure/Congestive Heart Failure	46	47
Pulmonary Dysfunction	41	42
Pneumonia	40	40
Epistaxis	37	38
Liver Damage/Dysfunction	34	34
Stroke/CVA	34	34
Fatigue	32	35
Nodule	28	29
Apnea	22	23
Respiratory Failure	20	20
Bronchitis	20	20
Atrial Fibrillation	19	21
Pharyngitis	17	17
Pain	17	19
Unspecified Eye / Vision Problem	16	18
Unspecified Infection	16	17
Cardiac Arrest	16	16
Low Oxygen Saturation	15	16
Dry Eye(s)	15	15
Cardiovascular Insufficiency	15	15
Myocardial Infarction	15	15
Unspecified Gastrointestinal Problem	14	14
Renal Failure	14	14
High Blood Pressure/ Hypertension	14	14
Sneezing	14	16
Rash	12	13