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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 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 216 216
Material Split, Cut or Torn 63 63
Activation Problem 25 25
No Audible Alarm 4 4
Break 3 3
Collapse 2 2
Disconnection 2 2
Device Slipped 2 2
Defective Component 1 1
Device Tipped Over 1 1
Sparking 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Fell 1 1
Material Frayed 1 1
Loose or Intermittent Connection 1 1
Unintended System Motion 1 1
Self-Activation or Keying 1 1
Intermittent Continuity 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 310 310
Insufficient Information 4 4
No Consequences Or Impact To Patient 4 4
No Patient Involvement 3 3
Bruise/Contusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
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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