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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilizer, ethylene-oxide gas
Product CodeFLF
Regulation Number 880.6860
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 3 3
2019 2 2
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 2 2
Device Operates Differently Than Expected 2 2
Device Sensing Problem 2 2
Gas Leak 2 2
Overheating of Device 2 2
Failure to Sense 2 2
Temperature Problem 2 2
Device Displays Incorrect Message 1 1
Improper Chemical Reaction 1 1
Leak/Splash 1 1
Device Alarm System 1 1
Use of Incorrect Control Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 5 5
Chemical Exposure 4 4
Itching Sensation 2 2
Dizziness 2 2
No Consequences Or Impact To Patient 2 2
Sore Throat 1 1
No Known Impact Or Consequence To Patient 1 1
Eye Pain 1 1
Dyspnea 1 1

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