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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
2019 393 393
2020 281 281
2021 257 257
2022 264 264
2023 342 342
2024 78 78

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 444 444
Break 210 210
Use of Device Problem 151 151
Unintended Movement 85 85
Insufficient Information 85 85
Device Tipped Over 84 84
Device Fell 75 75
Fracture 61 61
Adverse Event Without Identified Device or Use Problem 58 58
Material Split, Cut or Torn 49 49
Appropriate Term/Code Not Available 39 39
Mechanical Problem 29 29
Improper or Incorrect Procedure or Method 28 28
Unstable 25 25
Unintended System Motion 21 21
Material Deformation 18 18
Unclear Information 18 18
Material Twisted/Bent 17 17
Naturally Worn 17 17
Device Dislodged or Dislocated 17 17
Sparking 15 15
Device Handling Problem 14 14
Device Slipped 13 13
Material Separation 13 13
Component Missing 13 13
Material Integrity Problem 11 11
Defective Component 9 9
Material Fragmentation 9 9
Loose or Intermittent Connection 8 8
Installation-Related Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Patient Device Interaction Problem 8 8
Overheating of Device 7 7
Positioning Failure 7 7
Fire 6 6
Material Rupture 6 6
No Apparent Adverse Event 6 6
Protective Measures Problem 6 6
Misassembly by Users 5 5
Inadequate or Insufficient Training 5 5
Crack 5 5
Electrical /Electronic Property Problem 5 5
Collapse 5 5
Component Incompatible 4 4
Disconnection 4 4
Off-Label Use 4 4
Smoking 4 4
Arcing 4 4
Defective Device 4 4
Contamination /Decontamination Problem 4 4
Electrical Shorting 4 4
Compatibility Problem 4 4
Mechanical Jam 4 4
Sharp Edges 4 4
Fail-Safe Did Not Operate 3 3
Noise, Audible 3 3
Mechanics Altered 3 3
Output Problem 3 3
Fail-Safe Problem 3 3
Device-Device Incompatibility 3 3
Product Quality Problem 3 3
Material Frayed 3 3
Misassembled 3 3
Material Erosion 3 3
Circuit Failure 3 3
Accessory Incompatible 2 2
Thermal Decomposition of Device 2 2
Material Disintegration 2 2
Entrapment of Device 2 2
Nonstandard Device 2 2
Melted 2 2
Failure to Power Up 2 2
Battery Problem 2 2
Flare or Flash 2 2
Inadequacy of Device Shape and/or Size 2 2
Microbial Contamination of Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Structural Problem 2 2
Temperature Problem 2 2
Component Misassembled 2 2
Incomplete or Inadequate Connection 2 2
Unintended Electrical Shock 2 2
Misassembly During Maintenance/Repair 2 2
Key or Button Unresponsive/not Working 2 2
Non Reproducible Results 1 1
Activation Problem 1 1
Misassembled During Installation 1 1
Physical Resistance/Sticking 1 1
Positioning Problem 1 1
Scratched Material 1 1
No Fail-Safe Mechanism 1 1
Difficult or Delayed Activation 1 1
Solder Joint Fracture 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Inadequate User Interface 1 1
Failure to Shut Off 1 1
Electrical Power Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 420 420
No Clinical Signs, Symptoms or Conditions 397 397
Bone Fracture(s) 152 152
Head Injury 145 145
No Consequences Or Impact To Patient 141 141
Laceration(s) 113 113
Bruise/Contusion 99 99
No Patient Involvement 89 89
No Known Impact Or Consequence To Patient 73 73
Pain 56 56
Insufficient Information 43 43
Hematoma 40 40
Death 39 39
Injury 29 29
Hip Fracture 26 26
Abrasion 23 23
Skin Tears 20 20
Hemorrhage/Bleeding 17 17
Limb Fracture 16 16
Concussion 14 14
Unspecified Tissue Injury 14 14
Intracranial Hemorrhage 12 12
Multiple Fractures 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Muscle/Tendon Damage 9 9
Fracture, Arm 9 9
No Information 7 7
Swelling/ Edema 7 7
Swelling 6 6
Physical Entrapment 6 6
Brain Injury 5 5
Vertebral Fracture 5 5
Electric Shock 5 5
Patient Problem/Medical Problem 4 4
Spinal Column Injury 4 4
Bacterial Infection 4 4
Contusion 4 4
Headache 4 4
Ecchymosis 3 3
Skull Fracture 3 3
Hemothorax 3 3
Damage to Ligament(s) 3 3
Tooth Fracture 3 3
Neck Pain 3 3
Discomfort 3 3
Suture Abrasion 3 3
Post Traumatic Wound Infection 2 2
Pressure Sores 2 2
Joint Dislocation 2 2
Loss of consciousness 2 2
No Code Available 2 2
Convulsion/Seizure 2 2
Confusion/ Disorientation 2 2
Pneumothorax 2 2
Strangulation 2 2
Chest Pain 2 2
Abdominal Pain 1 1
Crushing Injury 1 1
Cardiac Arrest 1 1
Emotional Changes 1 1
Eye Injury 1 1
Hearing Impairment 1 1
Sprain 1 1
Skin Discoloration 1 1
Inflammation 1 1
Liver Laceration(s) 1 1
Muscle Weakness 1 1
Hemorrhage, Cerebral 1 1
Fatigue 1 1
Superficial (First Degree) Burn 1 1
Suicidal Ideation 1 1
Blister 1 1
Localized Skin Lesion 1 1
Nodule 1 1
Respiratory Failure 1 1
Spinal Cord Injury 1 1
Anxiety 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 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 Community Products, LLC II Oct-22-2019
8 Getinge Dominican Republic SA II Sep-13-2021
9 Handicare AB II Oct-09-2020
10 Handicare AB II May-09-2020
11 Hill-Rom, Inc. II Mar-11-2022
12 Hill-Rom, Inc. II Feb-16-2022
13 Hill-Rom, Inc. II Sep-30-2021
14 Hill-Rom, Inc. I Jan-29-2021
15 Human Care Hc Sweden Ab II Apr-05-2024
16 Human Care USA, Inc. II Mar-31-2022
17 Med-Mizer, Inc. II Mar-02-2023
18 Moller Vital II May-16-2019
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