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
Moisture or Humidity Problem	14	14
Obstruction of Flow	14	14
Leak/Splash	13	13
Crack	13	13
Defective Device	13	13
Gas/Air Leak	12	12
Material Split, Cut or Torn	11	11
Material Separation	9	9
Fitting Problem	7	7
Break	7	7
Gradient Increase	5	5
Difficult or Delayed Activation	4	4
Fluid/Blood Leak	3	3
Loose or Intermittent Connection	3	3
Appropriate Term/Code Not Available	3	3
Contamination /Decontamination Problem	3	3
Filtration Problem	3	3
Mechanical Problem	3	3
Disconnection	3	3
Defective Component	2	2
Use of Device Problem	2	2
Complete Blockage	2	2
Incomplete or Inadequate Connection	2	2
Material Deformation	2	2
Incorrect Measurement	2	2
Tear, Rip or Hole in Device Packaging	2	2
Gas Output Problem	2	2
Unsealed Device Packaging	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Insufficient Information	1	1
Patient Device Interaction Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Patient-Device Incompatibility	1	1
Excess Flow or Over-Infusion	1	1
Delivered as Unsterile Product	1	1
Material Rupture	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
No Apparent Adverse Event	1	1
Fracture	1	1
Device Contaminated During Manufacture or Shipping	1	1
Connection Problem	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	104	104
Insufficient Information	20	20
Unspecified Respiratory Problem	11	11
Low Oxygen Saturation	8	8
Dyspnea	4	4
Respiratory Arrest	3	3
Cardiac Arrest	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Aspiration/Inhalation	2	2
Malaise	2	2
Bradycardia	2	2
Cyanosis	1	1
High Blood Pressure/ Hypertension	1	1
Hypoventilation	1	1
Sneezing	1	1
Diaphoresis	1	1
Skin Inflammation/ Irritation	1	1
Foreign Body Reaction	1	1
Discomfort	1	1
Anxiety	1	1
Hypoxia	1	1
Respiratory Insufficiency	1	1
Airway Obstruction	1	1
Ventilator Dependent	1	1