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	1579	1579
Battery Problem	503	503
Inadequate User Interface	252	252
Electrical /Electronic Property Problem	166	166
Power Problem	134	134
Failure of Device to Self-Test	123	123
Failure to Charge	122	122
Device Displays Incorrect Message	119	119
Failure to Power Up	113	113
Failure to Calibrate	97	97
Inappropriate Tactile Prompt/Feedback	77	77
Complete Loss of Power	71	71
Unexpected Shutdown	68	68
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	14	14
Output Problem	13	13
Inappropriate or Unexpected Reset	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
Accessory Incompatible	9	9
No Tactile Prompts/Feedback	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
Moisture Damage	4	4
Contamination	4	4
Failure to Run on Battery	4	4
Alarm Not Visible	4	4
False Alarm	4	4
Application Program Freezes, Becomes Nonfunctional	4	4
Defective Component	4	4
Temperature Problem	3	3
Disconnection	3	3
Use of Device Problem	3	3
Break	3	3
Particulates	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2637	2637
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