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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, obstetric (and accessories)
Regulation Description Obstetric table and accessories.
Product CodeKNC
Regulation Number 884.4900
Device Class 2

MDR Year MDR Reports MDR Events
2021 25 25
2022 25 25
2023 45 45
2024 71 71
2025 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 184 184
Material Split, Cut or Torn 54 54
Activation Problem 21 21
No Audible Alarm 4 4
Break 3 3
Disconnection 2 2
Device Slipped 2 2
Collapse 2 2
Material Frayed 1 1
Sparking 1 1
Device Tipped Over 1 1
Crack 1 1
Device Fell 1 1
Defective Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Intermittent Continuity 1 1
Unintended System Motion 1 1
Self-Activation or Keying 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 265 265
Insufficient Information 4 4
No Consequences Or Impact To Patient 4 4
No Patient Involvement 3 3
Bruise/Contusion 2 2
Hypersensitivity/Allergic reaction 1 1
Neck Pain 1 1
Dyspnea 1 1
Fall 1 1
Pain 1 1
Unspecified Respiratory Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II May-23-2025
2 Hill-Rom, Inc. II Jul-28-2021
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