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
Failure to Disconnect	37	37
Disconnection	10	10
Inflation Problem	6	6
Tear, Rip or Hole in Device Packaging	5	5
Defective Device	4	4
Mechanical Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
No Pressure	2	2
Misassembled	2	2
Material Puncture/Hole	1	1
Difficult to Remove	1	1
Air Leak	1	1
Loose or Intermittent Connection	1	1
Blocked Connection	1	1
Detachment of Device or Device Component	1	1
Gas Leak	1	1
Infusion or Flow Problem	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Pressure Problem	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	39	39
No Clinical Signs, Symptoms or Conditions	12	12
No Consequences Or Impact To Patient	12	12
Low Oxygen Saturation	10	10
Hypoxia	3	3
Apnea	2	2
Bradycardia	2	2
Death	2	2
Hyperglycemia	1	1
Low Blood Pressure/ Hypotension	1	1
Cardiopulmonary Arrest	1	1
Pulmonary Infarction	1	1
Ulceration	1	1
Impaired Healing	1	1
Skin Inflammation	1	1
Skin Tears	1	1
Test Result	1	1
Not Applicable	1	1
Anemia	1	1