TPLC - Total Product Life Cycle

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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	4482	4482
Corroded	233	233
Contamination	77	77
Adverse Event Without Identified Device or Use Problem	73	73
Nonstandard Device	46	46
Device Displays Incorrect Message	42	42
Electrical /Electronic Property Problem	40	40
Battery Problem	39	39
Unexpected Shutdown	36	36
Failure to Power Up	35	35
Output Problem	26	26
Power Problem	26	26
Pressure Problem	24	24
Device Alarm System	23	23
Insufficient Information	21	21
Therapeutic or Diagnostic Output Failure	20	20
Patient-Device Incompatibility	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
Failure to Charge	11	11
Noise, Audible	11	11
Defective Device	11	11
Material Integrity Problem	11	11
Failure to Calibrate	10	10
Mechanical Problem	10	10
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Display or Visual Feedback Problem	9	9
Self-Activation or Keying	9	9
Decrease in Pressure	8	8
Overheating of Device	7	7
Defective Alarm	6	6
Break	6	6
Fire	6	6
Loss of Power	6	6
Crack	6	6
No Display/Image	5	5
Temperature Problem	5	5
Component Missing	5	5
Failure to Run on Battery	4	4
Computer Software Problem	4	4
Communication or Transmission Problem	4	4
Inadequate User Interface	4	4
Contamination /Decontamination Problem	4	4
Calibration Problem	4	4
Computer Operating System Problem	4	4
Patient Device Interaction Problem	4	4
Unintended Power Up	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2875	2875
Unspecified Respiratory Problem	566	566
Dyspnea	566	566
Headache	533	533
Dizziness	312	312
Cancer	299	299
Cough	245	245
Sore Throat	232	232
Respiratory Tract Infection	207	207
No Patient Involvement	176	176
Asthma	175	175
Unspecified Kidney or Urinary Problem	151	151
Nausea	116	116
Skin Inflammation/ Irritation	106	106
Unspecified Heart Problem	104	104
Inflammation	100	100
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	86	86
Insufficient Information	85	85
Vomiting	80	80
No Known Impact Or Consequence To Patient	77	77
Hypersensitivity/Allergic reaction	77	77
Dry Mouth	67	67
No Consequences Or Impact To Patient	53	53
Chest Pain	49	49
Unspecified Hepatic or Biliary Problem	44	44
Sleep Dysfunction	42	42
Chronic Obstructive Pulmonary Disease (COPD)	36	36
Epistaxis	36	36
Heart Failure/Congestive Heart Failure	34	34
Stroke/CVA	31	31
Liver Damage/Dysfunction	31	31
Fatigue	28	28
Pneumonia	28	28
Apnea	22	22
Nodule	21	21
Respiratory Failure	18	18
Pharyngitis	17	17
Pain	16	16
Unspecified Eye / Vision Problem	15	15
Cardiac Arrest	15	15
Renal Failure	14	14
Pulmonary Dysfunction	14	14
Dry Eye(s)	14	14
Atrial Fibrillation	14	14
Sneezing	13	13
Bronchitis	13	13
Rash	12	12
Low Oxygen Saturation	12	12
Unspecified Infection	12	12
Unspecified Gastrointestinal Problem	11	11