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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
2021 28 91
2022 22 91
2023 29 131
2024 30 116
2025 26 114
2026 3 9

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 56 362
Device Fell 35 93
Incorrect Measurement 20 55
Mechanical Jam 7 18
Mechanical Problem 4 4
Patient Device Interaction Problem 3 3
Fluid/Blood Leak 3 6
Device Slipped 2 2
Break 2 2
Activation, Positioning or Separation Problem 1 1
Collapse 1 1
Defective Component 1 2
Sharp Edges 1 1
Difficult or Delayed Positioning 1 1
Product Quality Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 129 543
Insufficient Information 6 6
Fall 2 16
Bruise/Contusion 2 2
Cyanosis 1 1
Respiratory Arrest 1 1
Cardiac Arrest 1 1
Bradycardia 1 1
Physical Entrapment 1 1
Vertebral Fracture 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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