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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
Product CodeFSA
Regulation Number 880.5510
Device Class 1

MDR Year MDR Reports MDR Events
2018 367 367
2019 393 393
2020 281 281
2021 257 257
2022 264 264
2023 288 288

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 475 475
Break 263 263
Use of Device Problem 169 169
Unintended Movement 104 104
Device Tipped Over 89 89
Adverse Event Without Identified Device or Use Problem 83 83
Device Fell 78 78
Insufficient Information 75 75
Fracture 69 69
Material Split, Cut or Torn 53 53
Detachment Of Device Component 39 39
Mechanical Problem 30 30
Improper or Incorrect Procedure or Method 30 30
Appropriate Term/Code Not Available 30 30
Unstable 26 26
Unintended System Motion 21 21
Material Deformation 20 20
Device Handling Problem 19 19
Material Twisted/Bent 19 19
Material Rupture 19 19
Unclear Information 18 18
Installation-Related Problem 17 17
Device Dislodged or Dislocated 17 17
Material Separation 17 17
Component Missing 16 16
Naturally Worn 16 16
Sparking 15 15
Device Slipped 14 14
Crack 13 13
Loose or Intermittent Connection 12 12
Material Integrity Problem 12 12
Material Fragmentation 11 11
Inadequate or Insufficient Training 10 10
Defective Component 10 10
Positioning Failure 8 8
Therapeutic or Diagnostic Output Failure 8 8
Patient Device Interaction Problem 8 8
Protective Measures Problem 7 7
Fire 7 7
Electrical /Electronic Property Problem 6 6
Component Falling 6 6
No Apparent Adverse Event 6 6
Mechanical Jam 5 5
Misassembly by Users 5 5
Thermal Decomposition of Device 5 5
Disconnection 5 5
Collapse 5 5
Material Frayed 5 5
Overheating of Device 4 4
Misassembled 4 4
Smoking 4 4
Off-Label Use 4 4
Product Quality Problem 4 4
Battery Problem 4 4
Contamination /Decontamination Problem 4 4
Structural Problem 4 4
Defective Device 4 4
Mechanics Altered 4 4
Electrical Shorting 4 4
Sharp Edges 4 4
Fail-Safe Did Not Operate 4 4
Unintended Electrical Shock 3 3
Fail-Safe Problem 3 3
Human Factors Issue 3 3
Output Problem 3 3
Noise, Audible 3 3
Melted 3 3
Material Erosion 3 3
Circuit Failure 3 3
Component Incompatible 3 3
Accessory Incompatible 2 2
Entrapment of Device 2 2
Material Disintegration 2 2
Nonstandard Device 2 2
Device Emits Odor 2 2
Solder Joint Fracture 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Remains Activated 2 2
Failure to Power Up 2 2
Inadequacy of Device Shape and/or Size 2 2
Sticking 2 2
Microbial Contamination of Device 2 2
Scratched Material 2 2
Temperature Problem 2 2
Inadequate User Interface 2 2
Compatibility Problem 2 2
Failure to Shut Off 2 2
Flare or Flash 2 2
Device Operates Differently Than Expected 2 2
Device-Device Incompatibility 2 2
Component Misassembled 2 2
Misassembled During Installation 2 2
Incomplete or Inadequate Connection 2 2
Misassembly During Maintenance/Repair 2 2
Key or Button Unresponsive/not Working 2 2
Activation Problem 1 1
Physical Resistance/Sticking 1 1
Non Reproducible Results 1 1
Electrical Power Problem 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 528 528
No Clinical Signs, Symptoms or Conditions 339 339
No Consequences Or Impact To Patient 233 233
Bone Fracture(s) 186 186
Head Injury 157 157
No Known Impact Or Consequence To Patient 124 124
Laceration(s) 123 123
Bruise/Contusion 116 116
No Patient Involvement 106 106
Pain 67 67
Death 56 56
Injury 54 54
Hematoma 47 47
Insufficient Information 32 32
Hip Fracture 29 29
Abrasion 28 28
Skin Tears 22 22
Hemorrhage/Bleeding 17 17
Concussion 14 14
Limb Fracture 14 14
Unspecified Tissue Injury 13 13
Fracture, Arm 13 13
No Information 10 10
Intracranial Hemorrhage 10 10
Multiple Fractures 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Swelling 9 9
Electric Shock 8 8
Muscle/Tendon Damage 8 8
Patient Problem/Medical Problem 7 7
Swelling/ Edema 7 7
Contusion 7 7
Physical Entrapment 6 6
Brain Injury 5 5
Sprain 5 5
Tooth Fracture 5 5
Vertebral Fracture 5 5
No Code Available 4 4
Headache 4 4
Bacterial Infection 4 4
Damage to Ligament(s) 4 4
Hemorrhage, Cerebral 4 4
Skull Fracture 3 3
Spinal Column Injury 3 3
Pneumothorax 3 3
Hemothorax 3 3
Ecchymosis 3 3
Neck Pain 3 3
Discomfort 3 3
Suture Abrasion 3 3
Post Traumatic Wound Infection 2 2
Joint Dislocation 2 2
Loss of consciousness 2 2
Confusion/ Disorientation 2 2
Pressure Sores 2 2
Chest Pain 2 2
Crushing Injury 2 2
Convulsion/Seizure 2 2
Suicidal Ideation 1 1
Superficial (First Degree) Burn 1 1
Blister 1 1
Localized Skin Lesion 1 1
Nodule 1 1
Fatigue 1 1
Hearing Impairment 1 1
Electrocution 1 1
Emotional Changes 1 1
Eye Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Liver Laceration(s) 1 1
Muscle Weakness 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Anxiety 1 1
Joint Disorder 1 1
Strangulation 1 1
Abdominal Pain 1 1
Tissue Damage 1 1
Vomiting 1 1
Tingling 1 1
Blood Loss 1 1
Missing Value Reason 1 1
Spinal Cord Injury 1 1
Respiratory Failure 1 1

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 POLSKA Sp. z.o.o. II Dec-07-2018
4 Arjohuntleigh Magog II Aug-07-2018
5 Arjohuntleigh Magog, Inc. II May-24-2023
6 Arjohuntleigh Magog, Inc. II Sep-16-2021
7 Arjohuntleigh Magog, Inc. II Feb-09-2021
8 Autochair II Apr-18-2018
9 Baxter Healthcare Corporation II Mar-28-2022
10 Community Products, LLC II Oct-22-2019
11 Getinge Dominican Republic SA II Sep-13-2021
12 Handicare AB II Oct-09-2020
13 Handicare AB II May-09-2020
14 Hill-Rom, Inc. II Mar-11-2022
15 Hill-Rom, Inc. II Feb-16-2022
16 Hill-Rom, Inc. II Sep-30-2021
17 Hill-Rom, Inc. I Jan-29-2021
18 Human Care USA, Inc. II Mar-31-2022
19 Invacare Corporation II Dec-03-2018
20 Liko AB II Oct-12-2018
21 Med-Mizer, Inc. II Mar-02-2023
22 Moller Vital II May-16-2019
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