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
Defective Device	13	13
Crack	13	13
Gas/Air Leak	12	12
Material Split, Cut or Torn	11	11
Material Separation	9	9
Break	9	9
Fitting Problem	7	7
Gradient Increase	5	5
Disconnection	5	5
Difficult or Delayed Activation	4	4
Filtration Problem	3	3
Insufficient Information	3	3
Contamination /Decontamination Problem	3	3
Mechanical Problem	3	3
Appropriate Term/Code Not Available	3	3
Loose or Intermittent Connection	3	3
Fluid/Blood Leak	3	3
Complete Blockage	2	2
Defective Component	2	2
Incomplete or Inadequate Connection	2	2
Use of Device Problem	2	2
Material Deformation	2	2
Incorrect Measurement	2	2
Tear, Rip or Hole in Device Packaging	2	2
Gas Output Problem	2	2
Patient-Device Incompatibility	1	1
Unsealed Device Packaging	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Patient Device Interaction Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Device Contaminated During Manufacture or Shipping	1	1
Excess Flow or Over-Infusion	1	1
Compatibility Problem	1	1
Delivered as Unsterile Product	1	1
Material Rupture	1	1
Component or Accessory Incompatibility	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
No Apparent Adverse Event	1	1
Fracture	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	107	107
Insufficient Information	21	21
Unspecified Respiratory Problem	11	11
Low Oxygen Saturation	8	8
Dyspnea	6	6
Respiratory Arrest	3	3
Cardiac Arrest	3	3
Aspiration/Inhalation	2	2
Bradycardia	2	2
Malaise	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Skin Inflammation/ Irritation	1	1
Airway Obstruction	1	1
Ventilator Dependent	1	1
Diaphoresis	1	1
Respiratory Insufficiency	1	1
Cyanosis	1	1
Foreign Body Reaction	1	1
High Blood Pressure/ Hypertension	1	1
Hypoventilation	1	1
Hypoxia	1	1
Sneezing	1	1
Anxiety	1	1
Discomfort	1	1