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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sterilizer automated loading system
Definition Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.
Product CodePEC
Regulation Number 880.6880
Device Class 2

MDR Year MDR Reports MDR Events
2018 1 1
2019 7 7
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 3 3
Detachment of Device or Device Component 2 2
Break 1 1
Leak/Splash 1 1
Device Slipped 1 1
Mechanical Jam 1 1
Unintended Movement 1 1
Sharp Edges 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5 5
Injury 3 3
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1

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