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	1614	1614
Battery Problem	505	505
Inadequate User Interface	259	259
Electrical /Electronic Property Problem	166	166
Power Problem	136	136
Failure to Charge	124	124
Failure of Device to Self-Test	123	123
Failure to Power Up	121	121
Device Displays Incorrect Message	119	119
Failure to Calibrate	97	97
Inappropriate Tactile Prompt/Feedback	77	77
Complete Loss of Power	73	73
Unexpected Shutdown	71	71
Charging Problem	57	57
Therapeutic or Diagnostic Output Failure	34	34
Unexpected Therapeutic Results	29	29
Adverse Event Without Identified Device or Use Problem	29	29
Device Alarm System	24	24
Degraded	24	24
Premature Discharge of Battery	23	23
Display or Visual Feedback Problem	19	19
No Audible Alarm	15	15
Inappropriate or Unexpected Reset	13	13
Output Problem	13	13
Material Split, Cut or Torn	12	12
Key or Button Unresponsive/not Working	12	12
Insufficient Information	11	11
Circuit Failure	9	9
Capacitative Coupling	9	9
Pressure Problem	9	9
No Tactile Prompts/Feedback	9	9
Accessory Incompatible	9	9
Operating System Becomes Nonfunctional	8	8
Intermittent Loss of Power	7	7
Appropriate Term/Code Not Available	7	7
Mechanical Problem	6	6
No Display/Image	5	5
Nonstandard Device	5	5
Failure to Run on Battery	4	4
Defective Component	4	4
Alarm Not Visible	4	4
Contamination	4	4
Moisture Damage	4	4
Application Program Freezes, Becomes Nonfunctional	4	4
False Alarm	4	4
Temperature Problem	3	3
Disconnection	3	3
Use of Device Problem	3	3
Overheating of Device	3	3
Particulates	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2693	2693
No Consequences Or Impact To Patient	150	150
Insufficient Information	91	91
Low Oxygen Saturation	41	41
No Patient Involvement	16	16
Loss of consciousness	9	9
Respiratory Arrest	6	6
Cardiac Arrest	6	6
Dyspnea	6	6
Death	5	5
Aspiration/Inhalation	4	4
Respiratory Insufficiency	4	4
Respiratory Failure	4	4
Diaphoresis	3	3
Pneumonia	3	3
Swelling/ Edema	3	3
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Dizziness	2	2
Confusion/ Disorientation	2	2
Chest Pain	2	2
Discomfort	2	2
Cyanosis	1	1
Syncope/Fainting	1	1
Hypersensitivity/Allergic reaction	1	1
Pneumothorax	1	1
Dry Mouth	1	1
Abnormal Blood Gases	1	1
Abdominal Distention	1	1
Blister	1	1
Burning Sensation	1	1
Cardiopulmonary Arrest	1	1
Pain	1	1
Eye Injury	1	1
Tachycardia	1	1
Polydipsia	1	1
Hypoxia	1	1
Unspecified Respiratory Problem	1	1
Cancer	1	1
Lethargy	1	1