TPLC - Total Product Life Cycle

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Device	anesthesia breathing circuit kit (adult & pediatric)
Regulation Description	Anesthesia breathing circuit.
Definition	This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product Code	OFP
Regulation Number	868.5240
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	12	13
Leak/Splash	8	8
Loose or Intermittent Connection	6	10
Connection Problem	5	5
Fracture	4	4
Material Split, Cut or Torn	3	4
Disconnection	2	2
Mechanical Problem	2	2
Crack	2	2
Material Disintegration	2	2
Material Puncture/Hole	2	2
Material Integrity Problem	2	3
Obstruction of Flow	2	3
Infusion or Flow Problem	2	2
Explosion	2	2
Temperature Problem	2	2
Break	1	1
Burst Container or Vessel	1	1
Filling Problem	1	1
Defective Component	1	1
Material Fragmentation	1	1
Inaccurate Flow Rate	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Separation	1	2
Detachment of Device or Device Component	1	2
Appropriate Term/Code Not Available	1	1
Gas Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	33	39
Hypoxia	7	7
Insufficient Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	4
Low Oxygen Saturation	3	3
Respiratory Arrest	1	1
Aspiration/Inhalation	1	1
Paralysis	1	1
Bronchospasm	1	1
Low Blood Pressure/ Hypotension	1	1