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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device absorber, carbon-dioxide
Regulation Description Carbon dioxide absorber.
Product CodeBSF
Regulation Number 868.5310
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 1 1
2019 5 5
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 3 3
Absorber (CO2) 3 3
Crack 2 2
Unintended Ejection 1 1
Device Inoperable 1 1
Defective Device 1 1
Chemical Problem 1 1
Gas Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pressure Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
Injury 2 2
Burn(s) 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GETINGE US SALES LLC II Aug-30-2019
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