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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
2017 49 49
2018 6 6
2019 3 3
2020 14 14
2021 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Disconnect 37 37
Disconnection 10 10
Inflation Problem 6 6
Tear, Rip or Hole in Device Packaging 5 5
Defective Device 4 4
Mechanical Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
No Pressure 2 2
Misassembled 2 2
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Air Leak 1 1
Loose or Intermittent Connection 1 1
Blocked Connection 1 1
Detachment of Device or Device Component 1 1
Gas Leak 1 1
Infusion or Flow Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Pressure Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 39 39
No Clinical Signs, Symptoms or Conditions 12 12
No Consequences Or Impact To Patient 12 12
Low Oxygen Saturation 10 10
Hypoxia 3 3
Apnea 2 2
Bradycardia 2 2
Death 2 2
Hyperglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Cardiopulmonary Arrest 1 1
Pulmonary Infarction 1 1
Ulceration 1 1
Impaired Healing 1 1
Skin Inflammation 1 1
Skin Tears 1 1
Test Result 1 1
Not Applicable 1 1
Anemia 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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