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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
2018 37 37
2019 60 60
2020 44 44
2021 25 25
2022 25 25
2023 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 80 80
Unintended Movement 68 68
Loose or Intermittent Connection 22 22
Unintended System Motion 12 12
Defective Component 10 10
Material Split, Cut or Torn 5 5
No Audible Alarm 4 4
Self-Activation or Keying 4 4
Activation Problem 3 3
Break 3 3
Mechanical Problem 2 2
Device Alarm System 1 1
Defective Alarm 1 1
Collapse 1 1
Crack 1 1
Positioning Failure 1 1
Disconnection 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Component Missing 1 1
Defective Device 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 68 68
No Known Impact Or Consequence To Patient 22 22
No Consequences Or Impact To Patient 4 4
Insufficient Information 2 2
Neck Pain 1 1
Bruise/Contusion 1 1
Pain 1 1

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