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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
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
2018 6 6
2019 3 3
2020 14 14
2021 9 9
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 6 6
Material Puncture/Hole 5 5
Tear, Rip or Hole in Device Packaging 5 5
Defective Device 4 4
Inflation Problem 3 3
Mechanical Problem 3 3
No Pressure 2 2
Pressure Problem 1 1
Appropriate Term/Code Not Available 1 1
Product Quality Problem 1 1
Misassembled 1 1
Loose or Intermittent Connection 1 1
Blocked Connection 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Gas/Air Leak 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Consequences Or Impact To Patient 7 7
Low Oxygen Saturation 6 6
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 2 2
Bradycardia 2 2
Hyperglycemia 1 1
Hypoxia 1 1
Pulmonary Infarction 1 1
Ulceration 1 1
Skin Tears 1 1
Impaired Healing 1 1
Skin Inflammation 1 1
Anemia 1 1
Test Result 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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