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
Inflation Problem	6	6
Material Puncture/Hole	5	5
Tear, Rip or Hole in Device Packaging	5	5
Disconnection	5	5
Mechanical Problem	5	5
Defective Device	4	4
Break	3	3
Mechanical Jam	2	2
Material Split, Cut or Torn	2	2
Leak/Splash	2	2
Dent in Material	2	2
No Pressure	2	2
Misassembled	1	1
Gas/Air Leak	1	1
Failure to Deliver	1	1
Material Discolored	1	1
Loose or Intermittent Connection	1	1
Material Twisted/Bent	1	1
Improper Flow or Infusion	1	1
Material Integrity Problem	1	1
Device Markings/Labelling Problem	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23	23
Cardiac Arrest	8	8
Low Oxygen Saturation	6	6
Insufficient Information	6	6
No Consequences Or Impact To Patient	5	5
Respiratory Arrest	2	2
Bradycardia	2	2
No Known Impact Or Consequence To Patient	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypoxia	1	1
Skin Inflammation	1	1
Pulmonary Infarction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ROi CPS LLC	II	Jun-26-2020