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	1984	2042
Battery Problem	554	574
Inadequate User Interface	320	366
Power Problem	171	175
Electrical /Electronic Property Problem	170	172
Failure to Charge	149	165
Failure to Power Up	139	146
Failure of Device to Self-Test	123	134
Device Displays Incorrect Message	119	125
Failure to Calibrate	99	121
Unexpected Shutdown	95	103
Complete Loss of Power	91	96
Inappropriate Tactile Prompt/Feedback	77	77
Charging Problem	67	67
Therapeutic or Diagnostic Output Failure	41	47
Device Alarm System	39	41
Adverse Event Without Identified Device or Use Problem	34	41
Unexpected Therapeutic Results	32	43
Degraded	24	24
Display or Visual Feedback Problem	23	29
Premature Discharge of Battery	23	26
No Audible Alarm	22	24
Inappropriate or Unexpected Reset	15	19
Material Split, Cut or Torn	13	20
Output Problem	13	20
Key or Button Unresponsive/not Working	12	15
Insufficient Information	11	14
Structural Problem	10	10
Pressure Problem	10	10
No Tactile Prompts/Feedback	9	11
Accessory Incompatible	9	16
Capacitative Coupling	9	9
Circuit Failure	9	9
Appropriate Term/Code Not Available	8	11
Operating System Becomes Nonfunctional	8	15
No Display/Image	7	7
Intermittent Loss of Power	7	7
Mechanical Problem	6	6
Nonstandard Device	5	6
No Apparent Adverse Event	5	5
Contamination	5	9
Use of Device Problem	5	7
Application Program Freezes, Becomes Nonfunctional	4	4
False Alarm	4	4
Failure to Run on Battery	4	4
Disconnection	4	4
Moisture Damage	4	8
Alarm Not Visible	4	4
Defective Component	4	4
Temperature Problem	3	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3220	3377
No Consequences Or Impact To Patient	150	150
Insufficient Information	122	138
Low Oxygen Saturation	49	64
No Patient Involvement	16	16
Loss of consciousness	13	13
Dyspnea	9	12
Cardiac Arrest	9	13
Aspiration/Inhalation	7	7
Respiratory Failure	6	6
Respiratory Arrest	6	10
Cyanosis	5	5
Death	5	5
Swelling/ Edema	5	6
Unspecified Infection	4	4
Respiratory Insufficiency	4	4
Lethargy	3	3
Tachycardia	3	4
Pneumonia	3	3
Diaphoresis	3	5
Burning Sensation	2	2
Confusion/ Disorientation	2	3
Discomfort	2	4
Chest Pain	2	2
Dizziness	2	4
Polydipsia	2	2
Hypoxia	2	2
Unspecified Respiratory Problem	2	2
Dry Mouth	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Blister	1	1
Salivary Gland Problem	1	1
Cardiopulmonary Arrest	1	1
Abdominal Distention	1	1
Pain	1	1
Eye Injury	1	1
Abnormal Blood Gases	1	2
Stroke/CVA	1	1
Cancer	1	1
Pneumothorax	1	1
Hypersensitivity/Allergic reaction	1	1
Syncope/Fainting	1	1
Ventilator Dependent	1	1