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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device mask, oxygen, non-rebreathing
Regulation Description Nonrebreathing mask.
Product CodeKGB
Regulation Number 868.5570
Device Class 1

Device Problems
Detachment Of Device Component 26
Disconnection 18
Break 8
Defective Device 6
Connection Problem 6
Loose or Intermittent Connection 5
Failure To Adhere Or Bond 5
Gas Leak 4
Hole In Material 4
Device Damaged Prior to Use 4
Burst Container or Vessel 3
Leak/Splash 3
Inflation Problem 3
Fitting Problem 2
Material Rupture 2
Patient-Device Incompatibility 2
Detachment of Device or Device Component 2
Adverse Event Without Identified Device or Use Problem 1
Defective Component 1
Material Separation 1
Crack 1
Occlusion Within Device 1
Improper Flow or Infusion 1
No Flow 1
Total Device Problems 110


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