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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed, pediatric open hospital
Product CodeFMS
Regulation Number 880.5140
Device Class 2

MDR Year MDR Reports MDR Events
2019 30 103
2020 28 139
2021 28 91
2022 22 91
2023 29 130
2024 5 32

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 46 349
Device Fell 35 84
Incorrect Measurement 19 63
Positioning Problem 9 54
Mechanical Jam 7 8
Patient Device Interaction Problem 6 7
Break 4 4
Mechanical Problem 3 3
Sharp Edges 3 3
Device Dislodged or Dislocated 2 4
Defective Component 2 2
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Entrapment of Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Protective Measures Problem 1 1
Unintended Movement 1 1
Unintended System Motion 1 1
Product Quality Problem 1 1
Collapse 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 370
No Patient Involvement 40 208
Insufficient Information 6 6
No Consequences Or Impact To Patient 4 4
Physical Entrapment 2 3
Abrasion 2 3
Bruise/Contusion 2 2
Fall 1 1
Bone Fracture(s) 1 1
Pain 1 2
Concussion 1 1
Injury 1 1
No Known Impact Or Consequence To Patient 1 1
Vertebral Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PediaLift LLC II Feb-02-2020
2 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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