TPLC - Total Product Life Cycle

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Device	condenser, heat and moisture (artificial nose)
Regulation Description	Heat and moisture condenser (artificial nose).
Product Code	BYD
Regulation Number	868.5375
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Disconnection	24	24
Defective Device	14	14
Gas/Air Leak	13	13
Moisture or Humidity Problem	10	10
Leak/Splash	9	9
Material Separation	9	9
Obstruction of Flow	8	8
Fitting Problem	7	7
Break	7	7
Loose or Intermittent Connection	4	4
Material Split, Cut or Torn	4	4
Appropriate Term/Code Not Available	4	4
Difficult or Delayed Activation	4	4
Mechanical Problem	3	3
Filtration Problem	3	3
Contamination /Decontamination Problem	3	3
Tear, Rip or Hole in Device Packaging	3	3
Fluid/Blood Leak	2	2
Gas Output Problem	2	2
Complete Blockage	2	2
Contamination	2	2
No Apparent Adverse Event	2	2
Use of Device Problem	2	2
Detachment of Device or Device Component	2	2
Material Deformation	2	2
Incorrect Measurement	2	2
No Device Output	1	1
Connection Problem	1	1
Nonstandard Device	1	1
Device Dislodged or Dislocated	1	1
Fracture	1	1
Device Sensing Problem	1	1
Delivered as Unsterile Product	1	1
Excess Flow or Over-Infusion	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Patient Device Interaction Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Component	1	1
Unsealed Device Packaging	1	1
Patient-Device Incompatibility	1	1
Malposition of Device	1	1
Migration or Expulsion of Device	1	1
Device Contaminated During Manufacture or Shipping	1	1
Compatibility Problem	1	1
Component or Accessory Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	80	80
No Consequences Or Impact To Patient	26	26
Unspecified Respiratory Problem	11	11
Insufficient Information	9	9
Dyspnea	5	5
Low Oxygen Saturation	5	5
Cardiac Arrest	4	4
Respiratory Arrest	3	3
Aspiration/Inhalation	2	2
Malaise	2	2
No Known Impact Or Consequence To Patient	2	2
Foreign Body In Patient	2	2
Airway Obstruction	2	2
Cyanosis	1	1
High Blood Pressure/ Hypertension	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Sneezing	1	1
Respiratory Distress	1	1
Diaphoresis	1	1
Skin Inflammation/ Irritation	1	1
Foreign Body Reaction	1	1
Discomfort	1	1
No Patient Involvement	1	1
Anxiety	1	1
Hypoxia	1	1
Respiratory Insufficiency	1	1
Ventilator Dependent	1	1