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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
2026 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 249 249
Material Split, Cut or Torn 66 66
Activation Problem 29 29
Collapse 4 4
No Audible Alarm 4 4
Intermittent Continuity 3 3
Disconnection 2 2
Material Frayed 1 1
Sparking 1 1
Break 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
Activation Failure 1 1
Unintended System Motion 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 355 355
Insufficient Information 5 5
No Consequences Or Impact To Patient 4 4
No Patient Involvement 3 3
Bruise/Contusion 2 2
Hypersensitivity/Allergic reaction 1 1
Eye Irritation 1 1
Neck Pain 1 1
Dyspnea 1 1
Fall 1 1
Pain 1 1
Unspecified Respiratory Problem 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 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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