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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)
Product CodeKNC
Regulation Number 884.4900
Device Class 2

MDR Year MDR Reports MDR Events
2019 60 60
2020 44 44
2021 25 25
2022 25 25
2023 45 45
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 80 80
Device Slipped 54 54
Loose or Intermittent Connection 22 22
Material Split, Cut or Torn 15 15
Unintended System Motion 7 7
Defective Component 6 6
Activation Problem 5 5
Self-Activation or Keying 4 4
No Audible Alarm 4 4
Break 4 4
Collapse 1 1
Intermittent Continuity 1 1
Crack 1 1
Disconnection 1 1
Mechanical Problem 1 1
Device Alarm System 1 1
Defective Alarm 1 1
Component Missing 1 1
Defective Device 1 1
Device Tipped Over 1 1
Mechanical Jam 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 102 102
No Clinical Signs, Symptoms or Conditions 94 94
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 4 4
Bruise/Contusion 2 2
Insufficient Information 2 2
Pain 1 1
Neck Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom, Inc. II Jul-28-2021
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