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	2280	2315
Battery Problem	470	488
Inadequate User Interface	382	417
Power Problem	204	206
Failure to Power Up	168	174
Electrical /Electronic Property Problem	163	165
Failure to Charge	154	166
Complete Loss of Power	140	145
Unexpected Shutdown	111	118
Failure to Calibrate	93	115
Charging Problem	93	93
Inappropriate Tactile Prompt/Feedback	87	87
Device Alarm System	41	43
Therapeutic or Diagnostic Output Failure	34	38
Unexpected Therapeutic Results	34	45
Adverse Event Without Identified Device or Use Problem	30	35
Premature Discharge of Battery	24	27
No Audible Alarm	24	26
Insufficient Device Problem Information	21	23
Inappropriate or Unexpected Reset	18	22
Material Split, Cut or Torn	13	20
Display or Visual Feedback Problem	12	12
Structural Problem	10	10
Accessory Incompatible	9	16
No Tactile Prompts/Feedback	8	9
Appropriate Device Problem Term/Code Not Available	7	10
No Display/Image	7	7
Intermittent Loss of Power	7	7
No Apparent Adverse Event	6	6
Use of Device Problem	6	8
Defective Alarm	5	5
Moisture Damage	4	8
Connection Problem	4	4
Contamination	4	8
Alarm Not Visible	4	4
Material Integrity Problem	4	4
Overheating of Device	4	4
False Alarm	4	4
Device Markings/Labelling Problem	4	4
Disconnection	4	4
Failure of Device to Self-Test	2	2
Human-Device Interface Problem	2	2
Difficult to Open or Close	2	4
No Device Output	2	2
Failure to Run on Battery	2	2
Electrical Shorting	2	2
Detachment of Device or Device Component	2	2
Incorrect Measurement	2	2
Use of Incorrect Control/Treatment Settings	2	2
Moisture or Humidity Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3829	3986
Insufficient Information	136	152
No Consequences Or Impact To Patient	92	92
Low Oxygen Saturation	60	75
Loss of consciousness	16	16
Dyspnea	12	15
No Patient Involvement	11	11
Cardiac Arrest	11	15
Respiratory Failure	10	10
Cyanosis	8	8
Respiratory Arrest	5	9
Aspiration/Inhalation	5	5
Swelling/ Edema	5	6
Respiratory Insufficiency	4	4
Unspecified Infection	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Diaphoresis	3	5
Pneumonia	3	3
Tachycardia	3	4
Unspecified Respiratory Problem	3	3
Lethargy	3	3
Dizziness	2	4
Confusion/ Disorientation	2	3
Burning Sensation	2	2
Chest Pain	2	2
Discomfort	2	4
Dry Mouth	2	2
Polydipsia	2	2
Hypoxia	2	2
Nasal congestion	1	1
Pneumothorax	1	1
Abnormal Blood Gases	1	2
Abdominal Distention	1	1
Blister	1	1
Hypersensitivity/Allergic reaction	1	1
Death	1	1
Stroke/CVA	1	1
Salivary Gland Problem	1	1
Pain	1	1
Sleepiness/Drowsiness/Somnolence	1	1
Eye Injury	1	1
Blood Bicarbonate Increased	1	1
Increased Respiratory Rate	1	1
Syncope/Fainting	1	1
Sleep Dysfunction	1	1
Cancer	1	1
Ventilator Dependent	1	1
Decreased Respiratory Rate	1	1