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	2142	2200
Battery Problem	577	597
Inadequate User Interface	376	422
Power Problem	193	197
Electrical /Electronic Property Problem	165	167
Failure to Power Up	159	166
Failure to Charge	156	172
Failure of Device to Self-Test	122	133
Complete Loss of Power	116	121
Unexpected Shutdown	110	118
Device Displays Incorrect Message	102	108
Failure to Calibrate	92	114
Charging Problem	87	87
Inappropriate Tactile Prompt/Feedback	87	87
Device Alarm System	50	52
Therapeutic or Diagnostic Output Failure	46	52
Adverse Event Without Identified Device or Use Problem	35	42
Unexpected Therapeutic Results	34	45
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
Circuit Failure	10	10
Pressure Problem	10	10
No Display/Image	10	10
Structural Problem	10	10
Capacitative Coupling	9	9
No Tactile Prompts/Feedback	9	11
Accessory Incompatible	9	16
Appropriate Term/Code Not Available	8	11
Defective Alarm	8	8
Operating System Becomes Nonfunctional	8	15
Intermittent Loss of Power	7	7
Disconnection	6	6
Failure to Run on Battery	6	6
Use of Device Problem	6	8
Mechanical Problem	6	6
Connection Problem	6	6
Nonstandard Device	6	7
Contamination	5	9
Material Integrity Problem	5	5
Defective Device	5	5
Device Markings/Labelling Problem	5	5
No Apparent Adverse Event	5	5
Alarm Not Visible	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3579	3736
Insufficient Information	127	143
No Consequences Or Impact To Patient	92	92
Low Oxygen Saturation	54	69
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