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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 172 172

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 469 469
Break 214 214
Use of Device Problem 174 174
Device Tipped Over 92 92
Unintended Movement 87 87
Insufficient Information 87 87
Device Fell 84 84
Fracture 61 61
Adverse Event Without Identified Device or Use Problem 58 58
Material Split, Cut or Torn 56 56
Appropriate Term/Code Not Available 46 46
Improper or Incorrect Procedure or Method 30 30
Mechanical Problem 29 29
Unstable 27 27
Unintended System Motion 21 21
Material Deformation 18 18
Naturally Worn 18 18
Unclear Information 18 18
Material Twisted/Bent 17 17
Device Dislodged or Dislocated 17 17
Sparking 15 15
Component Missing 14 14
Device Handling Problem 14 14
Device Slipped 13 13
Material Separation 13 13
Material Integrity Problem 11 11
Defective Component 9 9
Material Fragmentation 9 9
Overheating of Device 8 8
Loose or Intermittent Connection 8 8
Installation-Related Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Patient Device Interaction Problem 8 8
Positioning Failure 7 7
Crack 6 6
Fire 6 6
Material Rupture 6 6
Inadequate or Insufficient Training 6 6
No Apparent Adverse Event 6 6
Protective Measures Problem 6 6
Misassembly by Users 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
Unintended Electrical Shock 3 3
Noise, Audible 3 3
Mechanics Altered 3 3
Output Problem 3 3
Fail-Safe Did Not Operate 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
Misassembly During Maintenance/Repair 2 2
Key or Button Unresponsive/not Working 2 2
Temperature Problem 2 2
Component Misassembled 2 2
Incomplete or Inadequate Connection 2 2
Activation Problem 1 1
Separation Problem 1 1
Premature Separation 1 1
Non Reproducible Results 1 1
Physical Resistance/Sticking 1 1
Positioning Problem 1 1
Scratched Material 1 1
No Fail-Safe Mechanism 1 1
Misassembled During Installation 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 447 447
No Clinical Signs, Symptoms or Conditions 423 423
Bone Fracture(s) 167 167
Head Injury 149 149
No Consequences Or Impact To Patient 141 141
Laceration(s) 120 120
Bruise/Contusion 110 110
No Patient Involvement 89 89
No Known Impact Or Consequence To Patient 73 73
Pain 58 58
Insufficient Information 48 48
Hematoma 44 44
Death 39 39
Injury 29 29
Hip Fracture 26 26
Abrasion 25 25
Skin Tears 21 21
Limb Fracture 18 18
Hemorrhage/Bleeding 17 17
Unspecified Tissue Injury 14 14
Concussion 14 14
Intracranial Hemorrhage 12 12
Multiple Fractures 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Muscle/Tendon Damage 9 9
Fracture, Arm 9 9
Swelling/ Edema 8 8
No Information 7 7
Vertebral Fracture 6 6
Physical Entrapment 6 6
Swelling 6 6
Skull Fracture 5 5
Brain Injury 5 5
Electric Shock 5 5
Spinal Column Injury 4 4
Bacterial Infection 4 4
Contusion 4 4
Headache 4 4
Patient Problem/Medical Problem 4 4
Ecchymosis 3 3
Hemothorax 3 3
Damage to Ligament(s) 3 3
Suture Abrasion 3 3
Discomfort 3 3
Tooth Fracture 3 3
Neck Pain 3 3
Post Traumatic Wound Infection 2 2
Confusion/ Disorientation 2 2
Pressure Sores 2 2
Anxiety 2 2
Joint Dislocation 2 2
Loss of consciousness 2 2
No Code Available 2 2
Convulsion/Seizure 2 2
Pneumothorax 2 2
Skin Discoloration 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
Inflammation 1 1
Liver Laceration(s) 1 1
Muscle Weakness 1 1
Hemorrhage, Cerebral 1 1
Fatigue 1 1
Suicidal Ideation 1 1
Superficial (First Degree) Burn 1 1
Blister 1 1
Localized Skin Lesion 1 1
Nodule 1 1
Respiratory Failure 1 1
Spinal Cord Injury 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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