TPLC - Total Product Life Cycle

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Device	tubing, pressure and accessories
Regulation Description	Pressure tubing and accessories.
Product Code	BYX
Regulation Number	868.5860
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Twisted/Bent	30	30
Detachment of Device or Device Component	18	18
Loose or Intermittent Connection	16	16
Connection Problem	13	13
Peeled/Delaminated	8	8
Gas/Air Leak	8	8
Disconnection	7	7
Material Split, Cut or Torn	6	6
Crack	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Insufficient Flow or Under Infusion	4	4
Corroded	4	4
Leak/Splash	3	3
Fitting Problem	3	3
Break	3	3
Obstruction of Flow	3	3
Infusion or Flow Problem	3	3
Difficult or Delayed Positioning	3	3
Burst Container or Vessel	2	2
Fire	2	2
Patient-Device Incompatibility	2	2
Material Integrity Problem	2	2
Positioning Failure	2	2
Unintended Ejection	2	2
Component Missing	2	2
Material Deformation	2	2
Pressure Problem	1	1
Mechanical Problem	1	1
Unintended Movement	1	2
Device Fell	1	1
Tidal Volume Fluctuations	1	1
Positioning Problem	1	1
Moisture Damage	1	1
Failure to Deliver	1	1
Material Fragmentation	1	1
Improper Flow or Infusion	1	1
Device Damaged by Another Device	1	1
Appropriate Term/Code Not Available	1	1
Fluid/Blood Leak	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	84	86
Low Oxygen Saturation	24	24
Insufficient Information	16	16
Skin Tears	4	4
Aspiration/Inhalation	3	3
Numbness	3	3
Dyspnea	3	3
Pain	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hematoma	2	2
Fall	2	2
Cough	2	2
Headache	2	2
Superficial (First Degree) Burn	1	1
Fatigue	1	1
Skin Inflammation/ Irritation	1	1
Cognitive Changes	1	1
Chemical Exposure	1	1
Paralysis	1	1
Partial thickness (Second Degree) Burn	1	1
Airway Obstruction	1	1
Ventilator Dependent	1	1
Decreased Respiratory Rate	1	1
Full thickness (Third Degree) Burn	1	1
Bruise/Contusion	1	1