TPLC - Total Product Life Cycle

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Device	continuous, ventilator, home use
Regulation Description	Continuous ventilator.
Definition	This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
Product Code	NOU
Regulation Number	868.5895
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Protective Measures Problem	2120	2178
Battery Problem	571	591
Inadequate User Interface	371	417
Power Problem	191	195
Electrical /Electronic Property Problem	165	167
Failure to Power Up	157	164
Failure to Charge	156	172
Failure of Device to Self-Test	122	133
Complete Loss of Power	110	115
Unexpected Shutdown	107	115
Device Displays Incorrect Message	102	108
Failure to Calibrate	92	114
Charging Problem	87	87
Inappropriate Tactile Prompt/Feedback	87	87
Therapeutic or Diagnostic Output Failure	46	52
Device Alarm System	44	46
Unexpected Therapeutic Results	34	45
Adverse Event Without Identified Device or Use Problem	34	41
Display or Visual Feedback Problem	27	33
No Audible Alarm	27	29
Premature Discharge of Battery	24	27
Degraded	20	20
Inappropriate or Unexpected Reset	19	23
Output Problem	14	21
Key or Button Unresponsive/not Working	14	17
Material Split, Cut or Torn	13	20
Insufficient Information	11	14
Pressure Problem	10	10
No Display/Image	10	10
Circuit Failure	10	10
Structural Problem	10	10
Capacitative Coupling	9	9
Accessory Incompatible	9	16
No Tactile Prompts/Feedback	9	11
Appropriate Term/Code Not Available	8	11
Operating System Becomes Nonfunctional	8	15
Defective Alarm	8	8
Intermittent Loss of Power	7	7
Disconnection	6	6
Nonstandard Device	6	7
Mechanical Problem	6	6
Connection Problem	6	6
Failure to Run on Battery	6	6
Device Markings/Labelling Problem	5	5
Use of Device Problem	5	7
Contamination	5	9
No Apparent Adverse Event	5	5
Material Integrity Problem	5	5
Application Program Freezes, Becomes Nonfunctional	4	4
False Alarm	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3535	3692
Insufficient Information	126	142
No Consequences Or Impact To Patient	92	92
Low Oxygen Saturation	52	67
Loss of consciousness	14	14
Dyspnea	12	15
No Patient Involvement	11	11
Respiratory Failure	10	10
Cardiac Arrest	9	13
Cyanosis	8	8
Aspiration/Inhalation	7	7
Swelling/ Edema	5	6
Respiratory Arrest	5	9
Unspecified Infection	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Respiratory Insufficiency	4	4
Lethargy	3	3
Unspecified Respiratory Problem	3	3
Tachycardia	3	4
Pneumonia	3	3
Diaphoresis	3	5
Burning Sensation	2	2
Chest Pain	2	2
Discomfort	2	4
Confusion/ Disorientation	2	3
Dizziness	2	4
Polydipsia	2	2
Hypoxia	2	2
Dry Mouth	2	2
Blister	1	1
Salivary Gland Problem	1	1
Abdominal Distention	1	1
Pain	1	1
Eye Injury	1	1
Abnormal Blood Gases	1	2
Increased Respiratory Rate	1	1
Pneumothorax	1	1
Hypersensitivity/Allergic reaction	1	1
Death	1	1
Stroke/CVA	1	1
Cancer	1	1
Syncope/Fainting	1	1
Ventilator Dependent	1	1
Sleep Dysfunction	1	1