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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
2020 44 44
2021 25 25
2022 25 25
2023 45 45
2024 71 71
2025 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 152 152
Material Split, Cut or Torn 44 44
Loose or Intermittent Connection 17 17
Activation Problem 15 15
Device Slipped 10 10
Defective Component 6 6
No Audible Alarm 4 4
Break 3 3
Self-Activation or Keying 3 3
Disconnection 2 2
Device Alarm System 1 1
Defective Alarm 1 1
Collapse 1 1
Intermittent Continuity 1 1
Crack 1 1
Material Frayed 1 1
Device Tipped Over 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Unintended System Motion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 206 206
No Patient Involvement 47 47
No Consequences Or Impact To Patient 4 4
Insufficient Information 3 3
Bruise/Contusion 2 2
Neck Pain 1 1
Dyspnea 1 1
Fall 1 1
Hypersensitivity/Allergic reaction 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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