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	5933	5933
Corroded	233	233
Contamination	227	227
Electrical /Electronic Property Problem	176	176
Adverse Event Without Identified Device or Use Problem	172	172
Circuit Failure	76	76
Unexpected Shutdown	61	61
Nonstandard Device	46	46
Failure to Power Up	24	24
Power Problem	21	21
Patient-Device Incompatibility	20	20
Contamination /Decontamination Problem	20	20
Device Emits Odor	19	19
Device Sensing Problem	19	19
Insufficient Information	19	19
Battery Problem	17	17
Material Integrity Problem	13	13
Mechanical Problem	12	12
Pressure Problem	10	10
Noise, Audible	9	9
No Display/Image	9	9
Device Displays Incorrect Message	9	9
Increase in Pressure	9	9
Therapeutic or Diagnostic Output Failure	8	8
Device Alarm System	7	7
No Apparent Adverse Event	6	6
Overheating of Device	6	6
Failure to Charge	5	5
Decrease in Pressure	5	5
Break	5	5
Fire	5	5
Defective Alarm	5	5
Defective Component	5	5
Defective Device	5	5
Device Contamination with Chemical or Other Material	4	4
Patient Device Interaction Problem	4	4
Excessive Heating	4	4
Complete Loss of Power	4	4
No Audible Alarm	3	3
Computer Software Problem	3	3
Smoking	3	3
Material Disintegration	3	3
Self-Activation or Keying	3	3
Failure to Run on Battery	3	3
Temperature Problem	3	3
Leak/Splash	3	3
Protective Measures Problem	2	2
Failure to Calibrate	2	2
Inaccurate Delivery	2	2
Display or Visual Feedback Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4192	4192
Unspecified Respiratory Problem	750	750
Headache	632	632
Dyspnea	600	600
Cancer	413	413
Dizziness	398	398
Cough	255	255
Sore Throat	242	242
Asthma	232	232
Insufficient Information	223	223
Respiratory Tract Infection	215	215
Unspecified Kidney or Urinary Problem	214	214
Nausea	150	150
Skin Inflammation/ Irritation	149	149
Inflammation	145	145
Unspecified Heart Problem	120	120
Vomiting	111	111
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	105	105
Hypersensitivity/Allergic reaction	99	99
Unspecified Hepatic or Biliary Problem	73	73
Dry Mouth	72	72
Chronic Obstructive Pulmonary Disease (COPD)	60	60
Chest Pain	55	55
Sleep Dysfunction	47	47
Heart Failure/Congestive Heart Failure	46	46
Pneumonia	38	38
Pulmonary Dysfunction	38	38
Epistaxis	37	37
Stroke/CVA	35	35
Liver Damage/Dysfunction	33	33
Fatigue	31	31
Nodule	26	26
No Patient Involvement	25	25
Apnea	23	23
Bronchitis	20	20
Atrial Fibrillation	19	19
Respiratory Failure	19	19
Pharyngitis	17	17
Low Oxygen Saturation	16	16
Pain	16	16
Cardiovascular Insufficiency	15	15
Dry Eye(s)	15	15
Cardiac Arrest	15	15
Unspecified Eye / Vision Problem	15	15
Renal Failure	14	14
Sneezing	14	14
Unspecified Infection	14	14
Myocardial Infarction	14	14
Unspecified Gastrointestinal Problem	14	14
High Blood Pressure/ Hypertension	13	13