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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	89	89
No Consequences Or Impact To Patient	26	26
Insufficient Information	17	17
Unspecified Respiratory Problem	11	11
Low Oxygen Saturation	8	8
Dyspnea	5	5
Cardiac Arrest	4	4
Respiratory Arrest	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Aspiration/Inhalation	2	2
Malaise	2	2
No Known Impact Or Consequence To Patient	2	2
Foreign Body In Patient	2	2
Bradycardia	2	2
Airway Obstruction	2	2
Cyanosis	1	1
High Blood Pressure/ Hypertension	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