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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 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 84 84
Unintended Movement 81 81
Loose or Intermittent Connection 22 22
Unintended System Motion 14 14
Material Split, Cut or Torn 13 13
Defective Component 11 11
Self-Activation or Keying 10 10
Device Alarm System 6 6
Device Operates Differently Than Expected 5 5
Activation Problem 5 5
No Audible Alarm 4 4
Break 4 4
Collapse 2 2
Component Falling 2 2
Crack 2 2
Mechanical Problem 2 2
Defective Alarm 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Positioning Failure 1 1
Disconnection 1 1
Leak/Splash 1 1
Intermittent Continuity 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Device Dislodged or Dislocated 1 1
Mechanical Jam 1 1
Positioning Problem 1 1
Component Missing 1 1
Defective Device 1 1
Device Tipped Over 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 121 121
No Clinical Signs, Symptoms or Conditions 91 91
No Known Impact Or Consequence To Patient 43 43
No Consequences Or Impact To Patient 11 11
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
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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