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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bed, therapeutic, ac-powered, adjustable home-use
Product CodeLLI
Regulation Number 880.5100
Device Class 2

MDR Year MDR Reports MDR Events
2019 95 95
2020 16 16
2021 3 3
2022 11 11
2023 20 20
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 76 76
Appropriate Term/Code Not Available 11 11
Temperature Problem 11 11
Adverse Event Without Identified Device or Use Problem 8 8
Fire 5 5
Electrical /Electronic Property Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Unintended Movement 4 4
Insufficient Information 4 4
Thermal Decomposition of Device 3 3
Break 2 2
Material Puncture/Hole 2 2
Device Slipped 2 2
Smoking 2 2
Use of Device Problem 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Positioning Problem 1 1
Human-Device Interface Problem 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Activation Failure 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Explosion 1 1
Sharp Edges 1 1
Device Fell 1 1
Separation Problem 1 1
Misassembled During Installation 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Perforation 1 1
Sparking 1 1
Patient-Device Incompatibility 1 1
Component or Accessory Incompatibility 1 1
Collapse 1 1
Mechanical Problem 1 1
Melted 1 1
Device Emits Odor 1 1
No Device Output 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 74 74
Fall 26 26
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 11 11
Laceration(s) 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Hematoma 4 4
Bone Fracture(s) 3 3
Burn(s) 3 3
Pain 2 2
Swelling 2 2
Injury 2 2
Electric Shock 2 2
No Patient Involvement 1 1
Hip Fracture 1 1
Pressure Sores 1 1
Physical Entrapment 1 1
Missing Value Reason 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Multiple Fractures 1 1
Abrasion 1 1
Death 1 1
Eye Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Craftmatic Industries, Inc. II Aug-04-2022
2 Invacare Corporation II Mar-04-2024
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