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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 12 12

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
Appropriate Term/Code Not Available 12 12
Unintended Movement 12 12
Break 9 9
Detachment Of Device Component 9 9
Insufficient Information 7 7
Fire 5 5
Misassembled 5 5
Electrical /Electronic Property Problem 5 5
Device Slipped 5 5
Use of Device Problem 5 5
Unstable 5 5
Improper or Incorrect Procedure or Method 4 4
Material Integrity Problem 4 4
Device Operates Differently Than Expected 3 3
Material Protrusion/Extrusion 3 3
No Apparent Adverse Event 3 3
Thermal Decomposition of Device 3 3
Smoking 3 3
Mechanical Problem 2 2
Installation-Related Problem 2 2
Missing Value Reason 2 2
Device Issue 2 2
Bent 2 2
Separation Problem 2 2
Loose or Intermittent Connection 2 2
Unintended System Motion 2 2
Device Maintenance Issue 2 2
Component Missing 2 2
Kinked 2 2
Material Puncture/Hole 2 2
Patient-Device Incompatibility 2 2
Failure to Power Up 1 1
Sparking 1 1
Human-Device Interface Problem 1 1
Misassembled During Installation 1 1
Melted 1 1
Overheating of Device 1 1
Material Torqued 1 1
Device Inoperable 1 1
Patient Device Interaction Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Component or Accessory Incompatibility 1 1
Mechanical Jam 1 1
Device Handling Problem 1 1
Component Falling 1 1
No Device Output 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 20 20
Laceration(s) 16 16
Hematoma 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Injury 7 7
Bone Fracture(s) 6 6
Electric Shock 3 3
Burn(s) 3 3
Pain 3 3
Physical Entrapment 3 3
Bruise/Contusion 3 3
Abrasion 2 2
Contusion 2 2
Swelling 2 2
Eye Injury 2 2
Fracture, Arm 1 1
Death 1 1
Hip Fracture 1 1
No Information 1 1
Sprain 1 1
Head Injury 1 1
Multiple Fractures 1 1
Thrombosis 1 1
Concussion 1 1
No Patient Involvement 1 1
Missing Value Reason 1 1
Shock 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Pressure Sores 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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