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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
2020 14 14
2021 9 9
2022 6 6
2023 5 5
2024 23 23
2025 4 4

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
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