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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lift, patient, non-ac-powered
Regulation Description Non-AC-powered patient lift.
Product CodeFSA
Regulation Number 880.5510
Device Class 1

MDR Year MDR Reports MDR Events
2020 281 281
2021 257 257
2022 264 264
2023 342 342
2024 371 371
2025 140 140

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 455 455
Use of Device Problem 188 188
Break 135 135
Insufficient Information 108 108
Mechanical Problem 85 85
Device Tipped Over 85 85
Device Fell 76 76
Unintended Movement 72 72
Material Split, Cut or Torn 60 60
Appropriate Term/Code Not Available 56 56
Fracture 49 49
Adverse Event Without Identified Device or Use Problem 48 48
Improper or Incorrect Procedure or Method 28 28
Naturally Worn 19 19
Unintended System Motion 19 19
Material Deformation 18 18
Sparking 18 18
Unstable 15 15
Material Twisted/Bent 15 15
Unclear Information 12 12
Component Missing 11 11
Device Slipped 10 10
Overheating of Device 10 10
Device Dislodged or Dislocated 10 10
Material Rupture 9 9
Material Separation 9 9
Defective Component 9 9
Device Handling Problem 8 8
No Apparent Adverse Event 8 8
Patient Device Interaction Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Material Integrity Problem 8 8
Loose or Intermittent Connection 7 7
Crack 6 6
Electrical /Electronic Property Problem 6 6
Installation-Related Problem 6 6
Protective Measures Problem 5 5
Inadequate or Insufficient Training 5 5
Material Fragmentation 5 5
Electrical Shorting 5 5
Misassembly by Users 5 5
Disconnection 5 5
Component Incompatible 4 4
Off-Label Use 4 4
Contamination /Decontamination Problem 4 4
Fire 4 4
Separation Problem 4 4
Compatibility Problem 4 4
Sharp Edges 4 4
Collapse 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 603 603
Fall 409 409
Bone Fracture(s) 158 158
Head Injury 147 147
Laceration(s) 115 115
Bruise/Contusion 112 112
Pain 60 60
Insufficient Information 58 58
No Consequences Or Impact To Patient 47 47
Hematoma 42 42
No Patient Involvement 41 41
Hip Fracture 25 25
Abrasion 25 25
Limb Fracture 20 20
Death 20 20
Hemorrhage/Bleeding 17 17
Unspecified Tissue Injury 15 15
Skin Tears 15 15
Multiple Fractures 12 12
Concussion 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
No Known Impact Or Consequence To Patient 11 11
Muscle/Tendon Damage 10 10
Intracranial Hemorrhage 10 10
Physical Entrapment 9 9
Swelling/ Edema 9 9
Injury 9 9
Vertebral Fracture 8 8
Joint Dislocation 5 5
Electric Shock 5 5
Skull Fracture 5 5
Bacterial Infection 4 4
Headache 4 4
Tooth Fracture 4 4
Brain Injury 4 4
Fracture, Arm 4 4
Cardiac Arrest 3 3
Swelling 3 3
Damage to Ligament(s) 3 3
Skin Discoloration 2 2
Post Traumatic Wound Infection 2 2
Confusion/ Disorientation 2 2
Convulsion/Seizure 2 2
Crushing Injury 2 2
Neck Pain 2 2
Chest Pain 2 2
Strangulation 2 2
Pressure Sores 2 2
Discomfort 2 2
Loss of consciousness 2 2

Recalls
Manufacturer Recall Class Date Posted
1 ARJOHUNTLEIGH POLSKA Sp. z.o.o. I May-21-2022
2 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Mar-06-2020
3 Arjohuntleigh Magog, Inc. II May-24-2023
4 Arjohuntleigh Magog, Inc. II Sep-16-2021
5 Arjohuntleigh Magog, Inc. II Feb-09-2021
6 Baxter Healthcare Corporation II Mar-28-2022
7 Getinge Dominican Republic SA II Sep-13-2021
8 Handicare AB II Oct-09-2020
9 Handicare AB II May-09-2020
10 Hill-Rom, Inc. II Mar-11-2022
11 Hill-Rom, Inc. II Feb-16-2022
12 Hill-Rom, Inc. II Sep-30-2021
13 Hill-Rom, Inc. I Jan-29-2021
14 Human Care Hc Sweden Ab II Apr-05-2024
15 Human Care USA, Inc. II Mar-31-2022
16 Med-Mizer, Inc. II Mar-02-2023
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