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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
2017 375 375
2018 365 365
2019 393 393
2020 281 281
2021 257 257

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 343 343
Break 268 268
Use of Device Problem 171 171
Adverse Event Without Identified Device or Use Problem 112 112
Detachment Of Device Component 107 107
Unintended Movement 98 98
Device Tipped Over 85 85
Device Fell 64 64
Material Split, Cut or Torn 48 48
Device Handling Problem 43 43
Fracture 38 38
Mechanical Problem 38 38
Installation-Related Problem 31 31
Insufficient Information 26 26
Improper or Incorrect Procedure or Method 25 25
Unstable 25 25
Material Separation 21 21
Inadequate or Insufficient Training 18 18
Device Dislodged or Dislocated 18 18
Material Deformation 16 16
Component Falling 16 16
Crack 15 15
Device Slipped 15 15
Component Missing 15 15
Material Twisted/Bent 15 15
Unclear Information 15 15
Material Rupture 13 13
Loose or Intermittent Connection 12 12
Material Fragmentation 9 9
Bent 9 9
Unintended System Motion 9 9
Naturally Worn 9 9
Device Operates Differently Than Expected 9 9
Material Integrity Problem 8 8
Device Issue 8 8
Positioning Failure 8 8
Defective Component 7 7
Battery Problem 7 7
Therapeutic or Diagnostic Output Failure 7 7
Noise, Audible 6 6
Off-Label Use 6 6
Thermal Decomposition of Device 6 6
Fire 6 6
Collapse 5 5
Leak/Splash 4 4
Material Frayed 4 4
Device Maintenance Issue 4 4
Circuit Failure 4 4
Electrical /Electronic Property Problem 4 4
Structural Problem 4 4
Fail-Safe Did Not Operate 4 4
Contamination /Decontamination Problem 4 4
Sparking 4 4
Electrical Shorting 4 4
Human Factors Issue 4 4
Mechanical Jam 4 4
Mechanics Altered 4 4
Protective Measures Problem 4 4
Defective Device 3 3
Positioning Problem 3 3
Misassembly by Users 3 3
Inadequacy of Device Shape and/or Size 3 3
Product Quality Problem 3 3
Smoking 3 3
Device Inoperable 3 3
Material Erosion 3 3
Accessory Incompatible 3 3
Component Incompatible 3 3
Misassembled 3 3
Fluid Leak 3 3
Device Emits Odor 2 2
Unintended Collision 2 2
Melted 2 2
Entrapment of Device 2 2
Disconnection 2 2
Material Disintegration 2 2
Sticking 2 2
Device Remains Activated 2 2
Failure to Power Up 2 2
Overheating of Device 2 2
Device Damaged Prior to Use 2 2
Microbial Contamination of Device 2 2
Solder Joint Fracture 2 2
Arcing 2 2
No Apparent Adverse Event 2 2
Patient Device Interaction Problem 2 2
Appropriate Term/Code Not Available 2 2
Misassembled During Installation 2 2
Unintended Electrical Shock 2 2
Sharp Edges 2 2
Scratched Material 2 2
Output Problem 2 2
Inadequate User Interface 2 2
Compatibility Problem 2 2
Failure to Shut Off 2 2
Flare or Flash 2 2
Device-Device Incompatibility 2 2
Malposition of Device 1 1
Device Or Device Fragments Location Unknown 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 540 540
No Consequences Or Impact To Patient 313 313
Bone Fracture(s) 190 190
No Known Impact Or Consequence To Patient 179 179
No Patient Involvement 130 130
Bruise/Contusion 117 117
Head Injury 115 115
Laceration(s) 106 106
No Clinical Signs, Symptoms or Conditions 103 103
Injury 80 80
Death 67 67
Pain 66 66
Hematoma 44 44
Abrasion 25 25
Hip Fracture 21 21
Skin Tears 21 21
Fracture, Arm 16 16
Insufficient Information 14 14
Limb Fracture 13 13
Not Applicable 12 12
No Information 12 12
Swelling 10 10
Patient Problem/Medical Problem 10 10
Contusion 9 9
Concussion 8 8
Unspecified Tissue Injury 8 8
Electric Shock 7 7
Hemorrhage/Bleeding 7 7
Hemorrhage, Cerebral 6 6
Intracranial Hemorrhage 6 6
Sprain 6 6
Physical Entrapment 6 6
Tooth Fracture 5 5
Swelling/ Edema 5 5
Multiple Fractures 4 4
Vertebral Fracture 4 4
No Code Available 4 4
Bacterial Infection 4 4
Ecchymosis 4 4
Headache 4 4
Hemothorax 3 3
Pneumothorax 3 3
Neck Pain 3 3
Discomfort 3 3
Suture Abrasion 3 3
Skull Fracture 3 3
Spinal Column Injury 3 3
Muscle/Tendon Damage 3 3
Convulsion/Seizure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Tissue Damage 2 2
Blood Loss 2 2
Post Traumatic Wound Infection 2 2
Respiratory Distress 2 2
Chest Pain 2 2
Skin Discoloration 2 2
Damage to Ligament(s) 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Fatigue 1 1
Hemorrhage, Subarachnoid 1 1
Hearing Impairment 1 1
Electrocution 1 1
Eye Injury 1 1
Wound Dehiscence 1 1
Abdominal Pain 1 1
Crushing Injury 1 1
Cellulitis 1 1
Vascular System (Circulation), Impaired 1 1
Missing Value Reason 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Vomiting 1 1
Tingling 1 1
Strangulation 1 1
Anxiety 1 1
Brain Injury 1 1
Joint Disorder 1 1
Loss of consciousness 1 1
Localized Skin Lesion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Mar-06-2020
2 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Dec-07-2018
3 Arjohuntleigh Magog II Aug-07-2018
4 Arjohuntleigh Magog, Inc. II Sep-16-2021
5 Arjohuntleigh Magog, Inc. II Feb-09-2021
6 Autochair II Apr-18-2018
7 Community Products, LLC II Oct-22-2019
8 ErgoSafe Products, LLC (DBA) Prism Medical II Feb-28-2017
9 Getinge Dominican Republic SA II Sep-13-2021
10 Handicare AB II Oct-09-2020
11 Handicare AB II May-09-2020
12 Handicare AB II Oct-11-2017
13 Handicare Usa Inc II Sep-15-2017
14 Hill-Rom, Inc. II Sep-30-2021
15 Hill-Rom, Inc. I Jan-29-2021
16 Invacare Corporation II Dec-03-2018
17 Liko AB II Oct-12-2018
18 Moller Vital II May-16-2019
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