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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
2014 11 11
2015 15 15
2017 2 2
2018 37 37
2019 60 60
2020 44 44
2021 25 25
2022 25 25
2023 45 45
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 94 94
Device Slipped 84 84
Loose or Intermittent Connection 22 22
Material Split, Cut or Torn 21 21
Unintended System Motion 14 14
Defective Component 11 11
Self-Activation or Keying 10 10
Device Alarm System 6 6
Activation Problem 5 5
Device Operates Differently Than Expected 5 5
Break 4 4
No Audible Alarm 4 4
Disconnection 2 2
Mechanical Problem 2 2
Crack 2 2
Collapse 2 2
Component Falling 2 2
Leak/Splash 1 1
Device Tipped Over 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Defective Device 1 1
Positioning Problem 1 1
Positioning Failure 1 1
Component Missing 1 1
Defective Alarm 1 1
Device Dislodged or Dislocated 1 1
Intermittent Continuity 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 121 121
No Clinical Signs, Symptoms or Conditions 113 113
No Known Impact Or Consequence To Patient 43 43
No Consequences Or Impact To Patient 11 11
Insufficient Information 2 2
Bruise/Contusion 2 2
Neck Pain 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom, Inc. II Jul-28-2021
2 Hill-Rom, Inc. II Sep-08-2016
3 Hill-Rom, Inc. II Sep-01-2014
4 Hill-Rom, Inc. II Jul-26-2012
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