TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	4914	4914
Corroded	233	233
Electrical /Electronic Property Problem	113	113
Adverse Event Without Identified Device or Use Problem	100	100
Contamination	95	95
Circuit Failure	68	68
Unexpected Shutdown	53	53
Nonstandard Device	46	46
Failure to Power Up	22	22
Patient-Device Incompatibility	20	20
Device Sensing Problem	19	19
Power Problem	19	19
Insufficient Information	18	18
Battery Problem	17	17
Device Emits Odor	14	14
Material Integrity Problem	12	12
Mechanical Problem	11	11
Pressure Problem	9	9
Device Displays Incorrect Message	9	9
Increase in Pressure	9	9
Noise, Audible	8	8
Therapeutic or Diagnostic Output Failure	8	8
Device Alarm System	7	7
Decrease in Pressure	5	5
Break	5	5
Fire	5	5
Defective Alarm	5	5
Defective Component	5	5
Defective Device	5	5
Failure to Charge	4	4
No Display/Image	4	4
No Apparent Adverse Event	4	4
Patient Device Interaction Problem	4	4
Contamination /Decontamination Problem	4	4
Device Contamination with Chemical or Other Material	3	3
No Audible Alarm	3	3
Excessive Heating	3	3
Complete Loss of Power	3	3
Material Disintegration	3	3
Self-Activation or Keying	3	3
Failure to Run on Battery	3	3
Temperature Problem	3	3
Inaccurate Delivery	2	2
Failure to Calibrate	2	2
Computer Software Problem	2	2
Protective Measures Problem	2	2
Overheating of Device	2	2
Electrical Shorting	2	2
Display or Visual Feedback Problem	2	2
Inadequate User Interface	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3170	3170
Unspecified Respiratory Problem	710	710
Headache	615	615
Dyspnea	578	578
Cancer	398	398
Dizziness	387	387
Cough	248	248
Sore Throat	237	237
Asthma	218	218
Respiratory Tract Infection	213	213
Unspecified Kidney or Urinary Problem	202	202
Insufficient Information	146	146
Nausea	145	145
Inflammation	141	141
Skin Inflammation/ Irritation	140	140
Unspecified Heart Problem	115	115
Vomiting	109	109
Hypersensitivity/Allergic reaction	97	97
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	94	94
Dry Mouth	68	68
Unspecified Hepatic or Biliary Problem	67	67
Chest Pain	53	53
Chronic Obstructive Pulmonary Disease (COPD)	45	45
Sleep Dysfunction	42	42
Heart Failure/Congestive Heart Failure	38	38
Epistaxis	36	36
Stroke/CVA	35	35
Pneumonia	35	35
Pulmonary Dysfunction	33	33
Liver Damage/Dysfunction	33	33
Fatigue	28	28
No Patient Involvement	25	25
Nodule	24	24
Apnea	23	23
Respiratory Failure	19	19
Bronchitis	18	18
Pharyngitis	17	17
Pain	16	16
Unspecified Eye / Vision Problem	15	15
Atrial Fibrillation	15	15
Cardiac Arrest	15	15
Sneezing	14	14
Renal Failure	14	14
Dry Eye(s)	14	14
Cardiovascular Insufficiency	14	14
Low Oxygen Saturation	12	12
Unspecified Gastrointestinal Problem	12	12
High Blood Pressure/ Hypertension	12	12
Rash	12	12
Unspecified Infection	12	12