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	55	55
Disconnection	10	10
Tear, Rip or Hole in Device Packaging	5	5
Inflation Problem	5	5
Mechanical Problem	3	3
Break	3	3
Defective Device	3	3
Adverse Event Without Identified Device or Use Problem	3	3
No Pressure	2	2
Misassembled	2	2
Detachment Of Device Component	2	2
Difficult to Remove	2	2
Separation Failure	2	2
Detachment of Device or Device Component	2	2
Device Operates Differently Than Expected	2	2
Air Leak	2	2
Gas Leak	1	1
Infusion or Flow Problem	1	1
Material Twisted/Bent	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Blocked Connection	1	1
Fracture	1	1
Material Puncture/Hole	1	1
Component Falling	1	1
Loose or Intermittent Connection	1	1
Sticking	1	1
Failure To Adhere Or Bond	1	1
Pressure Problem	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	48	48
No Consequences Or Impact To Patient	21	21
Low Oxygen Saturation	12	12
No Clinical Signs, Symptoms or Conditions	11	11
Hypoxia	6	6
Death	4	4
Respiratory Failure	3	3
Apnea	2	2
Bradycardia	2	2
Respiratory Distress	2	2
Impaired Healing	1	1
Test Result	1	1
Not Applicable	1	1
No Code Available	1	1
Hyperglycemia	1	1
Skin Tears	1	1
Skin Inflammation	1	1
Anemia	1	1
Cardiopulmonary Arrest	1	1
Low Blood Pressure/ Hypotension	1	1
Ulceration	1	1