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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, transfer, patient, manual
Regulation Description Manual patient transfer device.
Product CodeFMR
Regulation Number 880.6785
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 8 8
2022 6 6
2023 10 10
2024 10 10
2025 10 10
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 12 12
Electrical Overstress 6 6
Device Slipped 5 5
Unintended Electrical Shock 5 5
Electrostatic Discharge 5 5
Inflation Problem 3 3
Electrical /Electronic Property Problem 3 3
Material Split, Cut or Torn 2 2
Patient Device Interaction Problem 2 2
Insufficient Device Problem Information 2 2
Fire 1 1
Unintended Deflation 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Detachment of Device or Device Component 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Connection Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Fall 8 8
Electric Shock 5 5
Bone Fracture(s) 5 5
Pressure Sore/Ulcer 4 4
Pain 3 3
Head Injury 2 2
Numbness 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Laceration(s) 2 2
Joint Dislocation 1 1
Necrosis 1 1
Unspecified Musculoskeletal problem 1 1
Loss of Range of Motion 1 1
Insufficient Information 1 1
Swelling/ Edema 1 1
Skin Tears 1 1
Tissue Breakdown 1 1
Liver Laceration(s) 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

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