TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2019	3	3
2020	14	14
2021	9	9
2022	6	6
2023	3	3
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Disconnection	5	5
Tear, Rip or Hole in Device Packaging	5	5
Material Puncture/Hole	5	5
Inflation Problem	4	4
Defective Device	4	4
Mechanical Problem	4	4
No Pressure	2	2
Improper Flow or Infusion	1	1
Loose or Intermittent Connection	1	1
Device Markings/Labelling Problem	1	1
Gas/Air Leak	1	1
Material Twisted/Bent	1	1
Product Quality Problem	1	1
Material Integrity Problem	1	1
Material Discolored	1	1
Failure to Deliver	1	1
Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16	16
Low Oxygen Saturation	6	6
No Consequences Or Impact To Patient	5	5
Insufficient Information	4	4
Bradycardia	2	2
Cardiac Arrest	2	2
Hypoxia	1	1
Pulmonary Infarction	1	1
Skin Inflammation	1	1
No Known Impact Or Consequence To Patient	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

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