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
Inflation Problem	10	10
Break	9	9
Disconnection	5	5
Material Puncture/Hole	5	5
Material Integrity Problem	5	5
Tear, Rip or Hole in Device Packaging	5	5
Mechanical Problem	3	3
Defective Device	3	3
Gas/Air Leak	3	3
Leak/Splash	2	2
Material Split, Cut or Torn	2	2
No Pressure	2	2
Dent in Material	2	2
Mechanical Jam	2	2
Device Markings/Labelling Problem	1	1
Failure to Deliver	1	1
Material Discolored	1	1
Improper Flow or Infusion	1	1
Material Twisted/Bent	1	1
Misassembled	1	1
Product Quality Problem	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	27	27
Cardiac Arrest	12	12
Insufficient Information	8	8
Low Oxygen Saturation	7	7
No Consequences Or Impact To Patient	5	5
Respiratory Arrest	2	2
Bradycardia	2	2
Respiratory Failure	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pulmonary Infarction	1	1
Hypoxia	1	1

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