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
Crack	28	28
Obstruction of Flow	14	14
Moisture or Humidity Problem	14	14
Defective Device	13	13
Leak/Splash	13	13
Gas/Air Leak	12	12
Material Split, Cut or Torn	11	11
Break	10	10
Material Separation	9	9
Disconnection	8	8
Fitting Problem	7	7
Gradient Increase	5	5
Loose or Intermittent Connection	5	5
Difficult or Delayed Activation	4	4
Contamination /Decontamination Problem	3	3
Filtration Problem	3	3
Mechanical Problem	3	3
Fluid/Blood Leak	3	3
Insufficient Information	3	3
Appropriate Term/Code Not Available	3	3
Incomplete or Inadequate Connection	2	2
Gas Output Problem	2	2
Material Deformation	2	2
Complete Blockage	2	2
Incorrect Measurement	2	2
Use of Device Problem	2	2
Defective Component	2	2
Tear, Rip or Hole in Device Packaging	2	2
Component or Accessory Incompatibility	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Device Sensing Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Patient-Device Incompatibility	1	1
Compatibility Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1
Material Rupture	1	1
Excess Flow or Over-Infusion	1	1
Fracture	1	1
No Apparent Adverse Event	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	127	127
Insufficient Information	23	23
Unspecified Respiratory Problem	11	11
Low Oxygen Saturation	8	8
Dyspnea	6	6
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