TPLC - Total Product Life Cycle

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Device	continuous, ventilator, home use
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	1304	1304
Battery Problem	474	474
Inadequate User Interface	206	206
Electrical /Electronic Property Problem	164	164
Failure of Device to Self-Test	123	123
Device Displays Incorrect Message	120	120
Failure to Charge	116	116
Failure to Calibrate	112	112
Power Problem	103	103
Failure to Power Up	84	84
Inappropriate Tactile Prompt/Feedback	75	75
Unexpected Shutdown	63	63
Complete Loss of Power	53	53
Charging Problem	37	37
Therapeutic or Diagnostic Output Failure	30	30
Degraded	24	24
Premature Discharge of Battery	24	24
Unexpected Therapeutic Results	23	23
Device Alarm System	22	22
Adverse Event Without Identified Device or Use Problem	22	22
Display or Visual Feedback Problem	17	17
Output Problem	13	13
Key or Button Unresponsive/not Working	12	12
No Audible Alarm	11	11
Inappropriate or Unexpected Reset	11	11
Pressure Problem	10	10
No Tactile Prompts/Feedback	9	9
Accessory Incompatible	9	9
Capacitative Coupling	9	9
Circuit Failure	9	9
Operating System Becomes Nonfunctional	8	8
Insufficient Information	8	8
Material Split, Cut or Torn	8	8
Mechanical Problem	6	6
Nonstandard Device	5	5
No Display/Image	5	5
Intermittent Loss of Power	5	5
Application Program Freezes, Becomes Nonfunctional	4	4
Contamination	4	4
False Alarm	4	4
Moisture Damage	4	4
Failure to Run on Battery	4	4
Defective Component	4	4
Use of Device Problem	3	3
Human-Device Interface Problem	3	3
Overheating of Device	3	3
Particulates	3	3
Break	3	3
Temperature Problem	3	3
Appropriate Term/Code Not Available	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2186	2186
No Consequences Or Impact To Patient	181	181
Insufficient Information	84	84
Low Oxygen Saturation	31	31
No Patient Involvement	16	16
Death	7	7
Respiratory Arrest	6	6
Cardiac Arrest	6	6
Aspiration/Inhalation	4	4
Dyspnea	4	4
Loss of consciousness	4	4
Diaphoresis	3	3
No Known Impact Or Consequence To Patient	3	3
Pneumonia	3	3
Swelling/ Edema	3	3
Respiratory Insufficiency	3	3
Respiratory Failure	3	3
Unspecified Infection	2	2
Dizziness	2	2
Discomfort	2	2
Syncope/Fainting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Abnormal Blood Gases	1	1
No Information	1	1
Abdominal Distention	1	1
Blister	1	1
Confusion/ Disorientation	1	1
Cardiopulmonary Arrest	1	1
Pain	1	1
Eye Injury	1	1
Tachycardia	1	1
Hypoxia	1	1
Cancer	1	1