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	6273	6414
Contamination	351	353
Adverse Event Without Identified Device or Use Problem	254	256
Corroded	233	233
Electrical /Electronic Property Problem	227	227
Circuit Failure	115	115
Unexpected Shutdown	62	62
Nonstandard Device	48	60
Overheating of Device	34	34
Failure to Power Up	28	28
Device Sensing Problem	22	22
Contamination /Decontamination Problem	22	22
Power Problem	21	21
Patient-Device Incompatibility	21	25
Insufficient Information	20	20
Device Emits Odor	20	21
Battery Problem	17	17
Noise, Audible	16	16
Mechanical Problem	14	14
Material Integrity Problem	14	14
Thermal Decomposition of Device	12	12
Pressure Problem	10	10
No Display/Image	10	10
Increase in Pressure	10	10
Device Displays Incorrect Message	9	9
Device Alarm System	8	8
No Apparent Adverse Event	8	8
Therapeutic or Diagnostic Output Failure	8	8
Complete Loss of Power	6	6
Fire	6	6
Activation Problem	6	7
Patient Device Interaction Problem	6	6
Computer Software Problem	5	6
Defective Alarm	5	5
Device Contamination with Chemical or Other Material	5	5
Decrease in Pressure	5	5
Failure to Charge	5	5
Break	5	6
Defective Device	5	5
Defective Component	5	5
Excessive Heating	4	4
Temperature Problem	4	4
Failure to Run on Battery	4	4
No Audible Alarm	3	3
Failure to Calibrate	3	3
Crack	3	3
Communication or Transmission Problem	3	3
Material Disintegration	3	3
Self-Activation or Keying	3	3
Leak/Splash	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4615	4706
Unspecified Respiratory Problem	765	781
Headache	639	655
Dyspnea	609	629
Cancer	419	424
Dizziness	401	403
Insufficient Information	279	283
Cough	261	272
Sore Throat	251	256
Asthma	235	239
Unspecified Kidney or Urinary Problem	219	220
Respiratory Tract Infection	216	225
Nausea	154	154
Skin Inflammation/ Irritation	151	151
Inflammation	147	153
Unspecified Heart Problem	124	126
Vomiting	112	112
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	107	108
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	55	57
Sleep Dysfunction	48	57
Heart Failure/Congestive Heart Failure	46	47
Pulmonary Dysfunction	41	42
Pneumonia	40	40
Epistaxis	37	38
Stroke/CVA	34	34
Liver Damage/Dysfunction	33	33
Fatigue	32	35
Nodule	26	27
No Patient Involvement	25	25
Apnea	23	25
Respiratory Failure	20	20
Bronchitis	20	20
Atrial Fibrillation	19	21
Pharyngitis	17	17
Low Oxygen Saturation	17	18
Pain	17	19
Unspecified Eye / Vision Problem	16	18
Unspecified Infection	16	17
Dry Eye(s)	15	15
Cardiovascular Insufficiency	15	15
Cardiac Arrest	15	15
Renal Failure	14	14
Myocardial Infarction	14	14
Unspecified Gastrointestinal Problem	14	14
Sneezing	14	16
High Blood Pressure/ Hypertension	14	14