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U.S. Department of Health and Human Services

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 CodeOEV
Regulation Number 868.5915
Device Class 2

MDR Year MDR Reports MDR Events
2016 29 29
2017 49 49
2018 6 6
2019 3 3
2020 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Disconnect 55 55
Disconnection 8 8
Tear, Rip or Hole in Device Packaging 4 4
Defective Device 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Break 3 3
Inflation Problem 3 3
Mechanical Problem 2 2
Separation Failure 2 2
Difficult to Remove 2 2
Detachment Of Device Component 2 2
Air Leak 2 2
No Pressure 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Gas Leak 1 1
Infusion or Flow Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Pressure Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Blocked Connection 1 1
Failure To Adhere Or Bond 1 1
Tube 1 1
Valve(s) 1 1
Bag 1 1
Component Falling 1 1
Fracture 1 1
Sticking 1 1
Misassembled 1 1
Material Puncture/Hole 1 1
Loose or Intermittent Connection 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 10 10
No Clinical Signs, Symptoms or Conditions 6 6
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

Recalls
Manufacturer Recall Class Date Posted
1 ROi CPS LLC II Jun-26-2020
2 Vyaire Medical I May-10-2018
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