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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, powered
Product CodeINQ
Regulation Number 890.3760
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2021 1 1
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 2 2
Unintended System Motion 1 1
Failure to Sense 1 1
Solder Joint Fracture 1 1
Patient-Device Incompatibility 1 1
Electrical Shorting 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2
Bone Fracture(s) 2 2
Pain 1 1
Vertigo 1 1
Discomfort 1 1
No Known Impact Or Consequence To Patient 1 1
Partial thickness (Second Degree) Burn 1 1
Vertebral Fracture 1 1

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