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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
2014 8 8
2015 13 13
2016 4 4
2017 44 44
2018 17 17
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 77 77
Adverse Event Without Identified Device or Use Problem 28 28
Temperature Problem 15 15
Unintended Movement 12 12
Appropriate Term/Code Not Available 11 11
Break 9 9
Detachment Of Device Component 9 9
Insufficient Information 7 7
Fire 5 5
Misassembled 5 5
Unstable 5 5
Use of Device Problem 5 5
Device Slipped 5 5
Improper or Incorrect Procedure or Method 4 4
Electrical /Electronic Property Problem 4 4
Material Integrity Problem 4 4
Material Protrusion/Extrusion 3 3
Device Operates Differently Than Expected 3 3
No Apparent Adverse Event 3 3
Thermal Decomposition of Device 3 3
Bent 2 2
Kinked 2 2
Loose or Intermittent Connection 2 2
Device Maintenance Issue 2 2
Mechanical Problem 2 2
Unintended System Motion 2 2
Material Puncture/Hole 2 2
Smoking 2 2
Patient-Device Incompatibility 2 2
Component Missing 2 2
Device Issue 2 2
Separation Problem 2 2
Installation-Related Problem 2 2
Missing Value Reason 2 2
Device Handling Problem 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
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Human-Device Interface Problem 1 1
Material Torqued 1 1
Mechanical Jam 1 1
Misassembled During Installation 1 1
Positioning Problem 1 1
Split 1 1
Sparking 1 1
Component or Accessory Incompatibility 1 1
Device Inoperable 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Misconnection 1 1
Device Emits Odor 1 1
Material Perforation 1 1
No Device Output 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Melted 1 1
Material Fragmentation 1 1
Collapse 1 1
Component Falling 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 79 79
Fall 72 72
No Known Impact Or Consequence To Patient 29 29
No Clinical Signs, Symptoms or Conditions 17 17
Laceration(s) 16 16
Hematoma 9 9
Injury 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Bone Fracture(s) 6 6
Bruise/Contusion 3 3
Burn(s) 3 3
Pain 3 3
Electric Shock 3 3
Physical Entrapment 3 3
Swelling 2 2
Contusion 2 2
Abrasion 2 2
Eye Injury 2 2
Head Injury 1 1
Death 1 1
Thrombosis 1 1
Concussion 1 1
Pressure Sores 1 1
Shock 1 1
Sprain 1 1
Hip Fracture 1 1
Fracture, Arm 1 1
No Information 1 1
Missing Value Reason 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Multiple Fractures 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Craftmatic Industries, Inc. II Aug-04-2022
2 GF Health Products, Inc./d.b.a.Basic American Metal Products II May-11-2012
3 Invacare Corporation II Mar-04-2024
4 Invacare Corporation II Feb-09-2017
5 Invacare Corporation II Nov-14-2011
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