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	2036	2094
Battery Problem	566	586
Inadequate User Interface	334	380
Power Problem	183	187
Electrical /Electronic Property Problem	170	172
Failure to Charge	153	169
Failure to Power Up	141	148
Failure of Device to Self-Test	123	134
Device Displays Incorrect Message	119	125
Unexpected Shutdown	101	109
Failure to Calibrate	99	121
Complete Loss of Power	95	100
Inappropriate Tactile Prompt/Feedback	83	83
Charging Problem	79	79
Therapeutic or Diagnostic Output Failure	43	49
Device Alarm System	39	41
Adverse Event Without Identified Device or Use Problem	35	42
Unexpected Therapeutic Results	34	45
Display or Visual Feedback Problem	25	31
Degraded	24	24
Premature Discharge of Battery	23	26
No Audible Alarm	22	24
Inappropriate or Unexpected Reset	17	21
Output Problem	13	20
Material Split, Cut or Torn	13	20
Key or Button Unresponsive/not Working	12	15
Insufficient Information	11	14
Structural Problem	10	10
Pressure Problem	10	10
No Tactile Prompts/Feedback	9	11
Accessory Incompatible	9	16
Capacitative Coupling	9	9
Circuit Failure	9	9
Appropriate Term/Code Not Available	8	11
Operating System Becomes Nonfunctional	8	15
No Display/Image	7	7
Intermittent Loss of Power	7	7
Connection Problem	6	6
Mechanical Problem	6	6
Nonstandard Device	5	6
No Apparent Adverse Event	5	5
Use of Device Problem	5	7
Device Markings/Labelling Problem	5	5
Material Integrity Problem	5	5
Contamination	5	9
Application Program Freezes, Becomes Nonfunctional	4	4
Defective Component	4	4
False Alarm	4	4
Alarm Not Visible	4	4
Failure to Run on Battery	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3328	3485
No Consequences Or Impact To Patient	150	150
Insufficient Information	123	139
Low Oxygen Saturation	49	64
No Patient Involvement	16	16
Loss of consciousness	13	13
Dyspnea	11	14
Respiratory Failure	10	10
Cardiac Arrest	9	13
Cyanosis	7	7
Aspiration/Inhalation	7	7
Respiratory Arrest	6	10
Death	5	5
Swelling/ Edema	5	6
Unspecified Infection	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
Confusion/ Disorientation	2	3
Discomfort	2	4
Chest Pain	2	2
Dizziness	2	4
Polydipsia	2	2
Hypoxia	2	2
Dry Mouth	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Salivary Gland Problem	1	1
Cardiopulmonary Arrest	1	1
Blister	1	1
Pain	1	1
Eye Injury	1	1
Abdominal Distention	1	1
Abnormal Blood Gases	1	2
Stroke/CVA	1	1
Cancer	1	1
Pneumothorax	1	1
Hypersensitivity/Allergic reaction	1	1
Syncope/Fainting	1	1
Ventilator Dependent	1	1