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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 342 342
2024 107 107

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 513 513
Break 277 277
Use of Device Problem 190 190
Unintended Movement 112 112
Device Tipped Over 106 106
Insufficient Information 89 89
Device Fell 87 87
Adverse Event Without Identified Device or Use Problem 84 84
Fracture 69 69
Material Split, Cut or Torn 57 57
Appropriate Term/Code Not Available 42 42
Detachment Of Device Component 39 39
Mechanical Problem 34 34
Improper or Incorrect Procedure or Method 30 30
Unstable 27 27
Unintended System Motion 22 22
Material Deformation 20 20
Material Twisted/Bent 20 20
Device Handling Problem 19 19
Material Rupture 19 19
Naturally Worn 18 18
Unclear Information 18 18
Device Dislodged or Dislocated 17 17
Installation-Related Problem 17 17
Material Separation 17 17
Component Missing 16 16
Sparking 16 16
Device Slipped 14 14
Crack 14 14
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
Fire 8 8
Positioning Failure 8 8
Therapeutic or Diagnostic Output Failure 8 8
Patient Device Interaction Problem 8 8
Protective Measures Problem 7 7
Electrical /Electronic Property Problem 7 7
Overheating of Device 7 7
Component Falling 6 6
No Apparent Adverse Event 6 6
Sharp Edges 6 6
Misassembly by Users 5 5
Mechanical Jam 5 5
Thermal Decomposition of Device 5 5
Disconnection 5 5
Collapse 5 5
Material Frayed 5 5
Off-Label Use 5 5
Product Quality Problem 4 4
Smoking 4 4
Battery Problem 4 4
Contamination /Decontamination Problem 4 4
Arcing 4 4
Defective Device 4 4
Structural Problem 4 4
Misassembled 4 4
Component Incompatible 4 4
Mechanics Altered 4 4
Compatibility Problem 4 4
Electrical Shorting 4 4
Fail-Safe Did Not Operate 4 4
Unintended Electrical Shock 3 3
Fail-Safe Problem 3 3
Device-Device Incompatibility 3 3
Human Factors Issue 3 3
Output Problem 3 3
Noise, Audible 3 3
Circuit Failure 3 3
Material Erosion 3 3
Melted 3 3
Nonstandard Device 2 2
Device Emits Odor 2 2
Entrapment of Device 2 2
Material Disintegration 2 2
Accessory Incompatible 2 2
Solder Joint Fracture 2 2
Tear, Rip or Hole in Device Packaging 2 2
Sticking 2 2
Microbial Contamination of Device 2 2
Device Remains Activated 2 2
Failure to Power Up 2 2
Inadequacy of Device Shape and/or Size 2 2
Scratched Material 2 2
Temperature Problem 2 2
Inadequate User Interface 2 2
Device Operates Differently Than Expected 2 2
Failure to Shut Off 2 2
Flare or Flash 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
Non Reproducible Results 1 1
Physical Resistance/Sticking 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 574 574
No Clinical Signs, Symptoms or Conditions 408 408
No Consequences Or Impact To Patient 233 233
Bone Fracture(s) 198 198
Head Injury 169 169
Laceration(s) 142 142
Bruise/Contusion 128 128
No Known Impact Or Consequence To Patient 124 124
No Patient Involvement 106 106
Pain 72 72
Death 56 56
Injury 54 54
Hematoma 52 52
Insufficient Information 43 43
Hip Fracture 30 30
Abrasion 29 29
Skin Tears 24 24
Hemorrhage/Bleeding 19 19
Limb Fracture 16 16
Concussion 15 15
Unspecified Tissue Injury 14 14
Fracture, Arm 13 13
Intracranial Hemorrhage 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Multiple Fractures 10 10
No Information 10 10
Muscle/Tendon Damage 9 9
Swelling 9 9
Electric Shock 8 8
Patient Problem/Medical Problem 7 7
Contusion 7 7
Swelling/ Edema 7 7
Vertebral Fracture 6 6
Physical Entrapment 6 6
Brain Injury 5 5
Sprain 5 5
Tooth Fracture 5 5
Spinal Column Injury 4 4
Bacterial Infection 4 4
Headache 4 4
Hemorrhage, Cerebral 4 4
Damage to Ligament(s) 4 4
No Code Available 4 4
Pneumothorax 3 3
Hemothorax 3 3
Ecchymosis 3 3
Skull Fracture 3 3
Neck Pain 3 3
Discomfort 3 3
Suture Abrasion 3 3
Confusion/ Disorientation 2 2
Joint Dislocation 2 2
Loss of consciousness 2 2
Post Traumatic Wound Infection 2 2
Strangulation 2 2
Pressure Sores 2 2
Crushing Injury 2 2
Chest Pain 2 2
Convulsion/Seizure 2 2
Suicidal Ideation 1 1
Missing Value Reason 1 1
Blister 1 1
Localized Skin Lesion 1 1
Nodule 1 1
Abdominal Pain 1 1
Cardiac Arrest 1 1
Electrocution 1 1
Emotional Changes 1 1
Eye Injury 1 1
Hearing Impairment 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Fatigue 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Skin Discoloration 1 1
Liver Laceration(s) 1 1
Muscle Weakness 1 1
Anxiety 1 1
Joint Disorder 1 1
Tissue Damage 1 1
Vomiting 1 1
Tingling 1 1
Respiratory Failure 1 1
Spinal Cord Injury 1 1
Blood Loss 1 1
Superficial (First Degree) Burn 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 Hc Sweden Ab II Apr-05-2024
19 Human Care USA, Inc. II Mar-31-2022
20 Invacare Corporation II Dec-03-2018
21 Liko AB II Oct-12-2018
22 Med-Mizer, Inc. II Mar-02-2023
23 Moller Vital II May-16-2019
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