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	1410	1410
Battery Problem	484	484
Inadequate User Interface	220	220
Electrical /Electronic Property Problem	164	164
Failure to Charge	124	124
Failure of Device to Self-Test	123	123
Device Displays Incorrect Message	120	120
Failure to Calibrate	112	112
Power Problem	111	111
Failure to Power Up	94	94
Inappropriate Tactile Prompt/Feedback	77	77
Unexpected Shutdown	63	63
Complete Loss of Power	57	57
Charging Problem	43	43
Therapeutic or Diagnostic Output Failure	32	32
Unexpected Therapeutic Results	25	25
Adverse Event Without Identified Device or Use Problem	25	25
Premature Discharge of Battery	24	24
Device Alarm System	24	24
Degraded	24	24
Display or Visual Feedback Problem	19	19
No Audible Alarm	14	14
Output Problem	13	13
Key or Button Unresponsive/not Working	12	12
Inappropriate or Unexpected Reset	11	11
Insufficient Information	11	11
Pressure Problem	10	10
Circuit Failure	9	9
Capacitative Coupling	9	9
Material Split, Cut or Torn	9	9
Accessory Incompatible	9	9
No Tactile Prompts/Feedback	9	9
Operating System Becomes Nonfunctional	8	8
Mechanical Problem	6	6
Appropriate Term/Code Not Available	6	6
Intermittent Loss of Power	5	5
Nonstandard Device	5	5
No Display/Image	5	5
Moisture Damage	4	4
Failure to Run on Battery	4	4
Contamination	4	4
Alarm Not Visible	4	4
False Alarm	4	4
Defective Component	4	4
Application Program Freezes, Becomes Nonfunctional	4	4
Temperature Problem	3	3
Use of Device Problem	3	3
Particulates	3	3
Defective Alarm	3	3
Break	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2344	2344
No Consequences Or Impact To Patient	181	181
Insufficient Information	89	89
Low Oxygen Saturation	38	38
No Patient Involvement	16	16
Death	7	7
Respiratory Arrest	6	6
Cardiac Arrest	6	6
Loss of consciousness	6	6
Aspiration/Inhalation	4	4
Dyspnea	4	4
Respiratory Insufficiency	4	4
Respiratory Failure	4	4
Diaphoresis	3	3
No Known Impact Or Consequence To Patient	3	3
Pneumonia	3	3
Swelling/ Edema	3	3
Unspecified Infection	2	2
Dizziness	2	2
Discomfort	2	2
Cyanosis	1	1
Syncope/Fainting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Pneumothorax	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
Unspecified Respiratory Problem	1	1
Cancer	1	1