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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, obstetrical, ac-powered (and accessories)
Product CodeHDD
Regulation Number 884.4900
Device Class 2

MDR Year MDR Reports MDR Events
2019 14 28
2020 17 36
2021 19 37
2022 14 63
2023 19 59
2024 4 11

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 22 40
Positioning Failure 20 113
Sharp Edges 13 20
Device Fell 11 16
Electrical /Electronic Property Problem 8 16
Unintended System Motion 8 13
Positioning Problem 4 15
Overheating of Device 1 1
Device Slipped 1 1
Unstable 1 1
Device Tipped Over 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 177
No Patient Involvement 24 52
Insufficient Information 3 3
Pain 1 1
No Consequences Or Impact To Patient 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Linet Americas III Aug-12-2020
2 Linet Spol. S.r.o. II Mar-09-2019
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