TPLC - Total Product Life Cycle

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Device	cardiopulmonary resuscitation aid kit
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
Disconnection	6	6
Material Puncture/Hole	5	5
Tear, Rip or Hole in Device Packaging	5	5
Defective Device	4	4
Inflation Problem	3	3
Mechanical Problem	3	3
No Pressure	2	2
Pressure Problem	1	1
Appropriate Term/Code Not Available	1	1
Product Quality Problem	1	1
Misassembled	1	1
Loose or Intermittent Connection	1	1
Blocked Connection	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Gas/Air Leak	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Discolored	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16	16
No Consequences Or Impact To Patient	7	7
Low Oxygen Saturation	6	6
No Known Impact Or Consequence To Patient	3	3
Insufficient Information	2	2
Bradycardia	2	2
Hyperglycemia	1	1
Hypoxia	1	1
Pulmonary Infarction	1	1
Ulceration	1	1
Skin Tears	1	1
Impaired Healing	1	1
Skin Inflammation	1	1
Anemia	1	1
Test Result	1	1