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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 12 26

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 22 40
Positioning Failure 22 121
Sharp Edges 14 21
Device Fell 13 18
Electrical /Electronic Property Problem 10 19
Unintended System Motion 9 14
Positioning Problem 4 15
Device Slipped 1 1
Unstable 1 1
Device Tipped Over 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 66 192
No Patient Involvement 24 52
Insufficient Information 3 3
Injury 1 1
Pain 1 1
No Consequences Or Impact To Patient 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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