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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)
Regulation Description Obstetric table and accessories.
Product CodeHDD
Regulation Number 884.4900
Device Class 2

MDR Year MDR Reports MDR Events
2021 19 37
2022 14 63
2023 19 59
2024 19 43
2025 17 68
2026 3 6

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 25 161
Mechanical Problem 18 39
Sharp Edges 16 26
Device Fell 14 21
Electrical /Electronic Property Problem 10 18
Unintended System Motion 8 11
Device Slipped 2 2
Overheating of Device 1 1
Device Tipped Over 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89 274
Insufficient Information 2 2

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