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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device table, powered
Regulation Description Powered table.
Product CodeINQ
Regulation Number 890.3760
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 4 4
2018 2 2
2019 3 3
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Self-Activation or Keying 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Operates Differently Than Expected 2 2
Device Operational Issue 1 1
Mechanical Problem 1 1
Failure to Sense 1 1
Unintended Movement 1 1
Solder Joint Fracture 1 1
Material Integrity Problem 1 1
Electrical /Electronic Property Problem 1 1
Unintended System Motion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 3 3
Crushing Injury 1 1
Vertigo 1 1
Bone Fracture(s) 1 1
Pain 1 1
Discomfort 1 1
No Patient Involvement 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Oct-11-2018
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