TPLC - Total Product Life Cycle

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Device	cardiopulmonary resuscitation aid kit
Regulation Description	Manual emergency ventilator.
Definition	This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. 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	OEV
Regulation Number	868.5915
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	11	11
Blocked Connection	10	10
Inflation Problem	10	10
Material Split, Cut or Torn	6	8
Component Missing	6	6
Material Integrity Problem	5	5
Gas/Air Leak	5	5
Material Puncture/Hole	4	4
Dent in Material	4	4
Mechanical Problem	3	3
Disconnection	2	2
Leak/Splash	2	2
Incomplete or Inadequate Connection	2	2
Material Deformation	2	2
Mechanical Jam	2	2
Device Markings/Labelling Problem	1	1
Defective Device	1	1
Failure to Deliver	1	1
Material Discolored	1	1
Improper Flow or Infusion	1	1
Misassembled	1	1
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	42	42
Cardiac Arrest	12	14
Insufficient Information	10	10
Low Oxygen Saturation	7	7
Hypoxia	4	4
Cyanosis	2	2
Respiratory Arrest	2	4
Respiratory Failure	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pulmonary Infarction	1	1