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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
Regulation Description Pediatric medical crib.
Product CodeFMS
Regulation Number 880.5140
Device Class 2

MDR Year MDR Reports MDR Events
2020 28 139
2021 28 91
2022 22 91
2023 29 131
2024 30 116
2025 26 114
2026 9 30

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 67 469
Device Fell 43 119
Incorrect Measurement 24 68
Mechanical Jam 8 19
Patient Device Interaction Problem 5 6
Mechanical Problem 4 4
Sharp Edges 3 3
Fluid/Blood Leak 3 6
Device Dislodged or Dislocated 2 4
Break 2 2
Device Slipped 2 2
Defective Component 1 2
Protective Measures Problem 1 1
Difficult or Delayed Positioning 1 1
Positioning Problem 1 2
Activation, Positioning or Separation Problem 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 143 597
No Patient Involvement 16 111
Insufficient Information 6 6
Fall 3 17
Physical Entrapment 2 3
Bruise/Contusion 2 2
No Consequences Or Impact To Patient 2 2
Vertebral Fracture 1 1
Respiratory Arrest 1 1
Low Oxygen Saturation 1 1
No Known Impact Or Consequence To Patient 1 1
Pain 1 2
Abrasion 1 2
Cardiac Arrest 1 1
Concussion 1 1
Bradycardia 1 1
Cyanosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PediaLift LLC II Feb-02-2020
2 Stryker Medical Division of Stryker Corporation II Mar-19-2026
3 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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