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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, surgical with orthopedic accessories, ac-powered
Regulation Description Operating tables and accessories and operating chairs and accessories.
Product CodeJEA
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2021 40 40
2022 32 32
2023 33 33
2024 36 37
2025 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 37 37
Unintended Movement 25 25
Insufficient Information 20 20
Adverse Event Without Identified Device or Use Problem 14 14
Unexpected Shutdown 13 13
Device Slipped 9 9
Detachment of Device or Device Component 8 8
Device Fell 8 8
Unintended System Motion 6 6
Improper or Incorrect Procedure or Method 4 4
Break 4 4
Device Dislodged or Dislocated 4 4
Crack 4 4
Device Handling Problem 4 4
Fracture 3 3
Output Problem 3 3
Material Separation 3 3
Positioning Problem 3 3
Positioning Failure 3 4
Loss of or Failure to Bond 2 2
Overheating of Device 2 2
Connection Problem 2 2
Electrical Shorting 2 2
Misassembly by Users 2 2
Patient Device Interaction Problem 2 2
Smoking 2 2
Battery Problem 1 1
Moisture Damage 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Misconnection 1 1
Wireless Communication Problem 1 1
Patient-Device Incompatibility 1 1
Collapse 1 1
Physical Resistance/Sticking 1 1
No Apparent Adverse Event 1 1
Communication or Transmission Problem 1 1
Malposition of Device 1 1
Protective Measures Problem 1 1
Intermittent Continuity 1 1
Mechanical Problem 1 1
Fire 1 1
Entrapment of Device 1 1
Corroded 1 1
Electrical /Electronic Property Problem 1 2
Loose or Intermittent Connection 1 1
Fitting Problem 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 92 93
Fall 40 40
Insufficient Information 28 28
Bone Fracture(s) 4 4
Laceration(s) 4 4
Bruise/Contusion 4 4
Abrasion 3 3
Aspiration/Inhalation 2 2
Burn(s) 2 2
Muscle/Tendon Damage 2 2
Swelling/ Edema 2 2
Skin Tears 2 2
No Consequences Or Impact To Patient 2 2
Pressure Sores 2 2
Unintended Extubation 2 2
Damage to Ligament(s) 1 1
Arrhythmia 1 1
Pulmonary Dysfunction 1 1
Necrosis 1 1
Head Injury 1 1
Hematoma 1 1
Low Cardiac Output 1 1
Blister 1 1
Cardiac Arrest 1 1
Paresthesia 1 1
Paralysis 1 1
Nerve Damage 1 1
Numbness 1 1
No Patient Involvement 1 1
Pain 1 1
Hyperextension 1 1
Limb Fracture 1 1
Stenosis 1 1
Cardiovascular Insufficiency 1 1
Bacterial Infection 1 1
Paraplegia 1 1
Respiratory Insufficiency 1 1
Low Oxygen Saturation 1 1
Vertebral Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-21-2025
2 Baxter Healthcare Corporation II Oct-24-2024
3 Steris Corporation II Feb-24-2021
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