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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
2017 375 375
2018 365 365
2019 393 393
2020 281 281
2021 257 257
2022 190 190

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 403 403
Break 284 284
Use of Device Problem 184 184
Adverse Event Without Identified Device or Use Problem 114 114
Detachment Of Device Component 107 107
Unintended Movement 105 105
Device Tipped Over 105 105
Device Fell 70 70
Material Split, Cut or Torn 49 49
Fracture 47 47
Device Handling Problem 45 45
Mechanical Problem 41 41
Insufficient Information 39 39
Installation-Related Problem 31 31
Unstable 26 26
Improper or Incorrect Procedure or Method 26 26
Material Separation 24 24
Inadequate or Insufficient Training 18 18
Device Dislodged or Dislocated 18 18
Component Missing 17 17
Crack 16 16
Component Falling 16 16
Material Rupture 16 16
Material Deformation 16 16
Material Twisted/Bent 15 15
Unclear Information 15 15
Device Slipped 15 15
Loose or Intermittent Connection 13 13
Appropriate Term/Code Not Available 12 12
Naturally Worn 11 11
Unintended System Motion 10 10
Material Fragmentation 10 10
Bent 9 9
Sparking 9 9
Device Operates Differently Than Expected 9 9
Material Integrity Problem 9 9
Battery Problem 8 8
Device Issue 8 8
Positioning Failure 8 8
Therapeutic or Diagnostic Output Failure 8 8
Defective Component 7 7
Electrical Shorting 6 6
Patient Device Interaction Problem 6 6
Fire 6 6
Off-Label Use 6 6
Noise, Audible 6 6
Thermal Decomposition of Device 6 6
Electrical /Electronic Property Problem 5 5
Collapse 5 5
Mechanical Jam 5 5
Protective Measures Problem 5 5
Human Factors Issue 4 4
Fail-Safe Did Not Operate 4 4
Leak/Splash 4 4
Device Maintenance Issue 4 4
Smoking 4 4
Structural Problem 4 4
Defective Device 4 4
Disconnection 4 4
Circuit Failure 4 4
Material Frayed 4 4
Sharp Edges 4 4
Mechanics Altered 4 4
Contamination /Decontamination Problem 4 4
Positioning Problem 3 3
Misassembled 3 3
Material Erosion 3 3
Fluid Leak 3 3
Melted 3 3
Product Quality Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Accessory Incompatible 3 3
Device Inoperable 3 3
Component Incompatible 3 3
Misassembly by Users 3 3
Unintended Electrical Shock 3 3
Misassembled During Installation 2 2
Material Disintegration 2 2
Device Emits Odor 2 2
Failure to Power Up 2 2
Device-Device Incompatibility 2 2
Flare or Flash 2 2
Compatibility Problem 2 2
Incomplete or Inadequate Connection 2 2
Sticking 2 2
Unintended Collision 2 2
Solder Joint Fracture 2 2
Arcing 2 2
Nonstandard Device 2 2
Overheating of Device 2 2
Microbial Contamination of Device 2 2
Failure to Shut Off 2 2
Inadequate User Interface 2 2
Output Problem 2 2
No Apparent Adverse Event 2 2
Entrapment of Device 2 2
Device Remains Activated 2 2
Scratched Material 2 2
Key or Button Unresponsive/not Working 2 2
Device Damaged Prior to Use 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 573 573
No Consequences Or Impact To Patient 313 313
Bone Fracture(s) 202 202
No Clinical Signs, Symptoms or Conditions 180 180
No Known Impact Or Consequence To Patient 179 179
Head Injury 140 140
No Patient Involvement 130 130
Bruise/Contusion 122 122
Laceration(s) 118 118
Injury 80 80
Pain 69 69
Death 67 67
Hematoma 50 50
Hip Fracture 29 29
Abrasion 26 26
Skin Tears 24 24
Insufficient Information 22 22
Fracture, Arm 16 16
Hemorrhage/Bleeding 13 13
Limb Fracture 13 13
Not Applicable 12 12
No Information 12 12
Concussion 12 12
Patient Problem/Medical Problem 10 10
Swelling 10 10
Electric Shock 9 9
Contusion 9 9
Unspecified Tissue Injury 9 9
Intracranial Hemorrhage 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Multiple Fractures 7 7
Hemorrhage, Cerebral 6 6
Sprain 6 6
Physical Entrapment 6 6
Skull Fracture 5 5
Tooth Fracture 5 5
Swelling/ Edema 5 5
Muscle/Tendon Damage 5 5
Vertebral Fracture 4 4
No Code Available 4 4
Discomfort 4 4
Bacterial Infection 4 4
Ecchymosis 4 4
Headache 4 4
Hemothorax 3 3
Pneumothorax 3 3
Neck Pain 3 3
Suture Abrasion 3 3
Spinal Column Injury 3 3
Brain Injury 3 3
Pressure Sores 2 2
Tissue Damage 2 2
Loss of consciousness 2 2
Post Traumatic Wound Infection 2 2
Blood Loss 2 2
Respiratory Distress 2 2
Chest Pain 2 2
Skin Discoloration 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
Damage to Ligament(s) 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Hemorrhage, Subarachnoid 1 1
Fatigue 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
Partial thickness (Second Degree) Burn 1 1
Vascular System (Circulation), Impaired 1 1
Superficial (First Degree) Burn 1 1
Respiratory Failure 1 1
Spinal Cord Injury 1 1
Vomiting 1 1
Tingling 1 1
Strangulation 1 1
Anxiety 1 1
Joint Disorder 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 Sep-16-2021
6 Arjohuntleigh Magog, Inc. II Feb-09-2021
7 Autochair II Apr-18-2018
8 Baxter Healthcare Corporation II Mar-28-2022
9 Community Products, LLC II Oct-22-2019
10 ErgoSafe Products, LLC (DBA) Prism Medical II Feb-28-2017
11 Getinge Dominican Republic SA II Sep-13-2021
12 Handicare AB II Oct-09-2020
13 Handicare AB II May-09-2020
14 Handicare AB II Oct-11-2017
15 Handicare Usa Inc II Sep-15-2017
16 Hill-Rom, Inc. II Mar-11-2022
17 Hill-Rom, Inc. II Feb-16-2022
18 Hill-Rom, Inc. II Sep-30-2021
19 Hill-Rom, Inc. I Jan-29-2021
20 Human Care USA, Inc. II Mar-31-2022
21 Invacare Corporation II Dec-03-2018
22 Liko AB II Oct-12-2018
23 Moller Vital II May-16-2019
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