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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 38 40
2025 27 27
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 39 39
Unintended Movement 27 27
Insufficient Information 23 23
Adverse Event Without Identified Device or Use Problem 15 15
Unexpected Shutdown 13 13
Device Slipped 10 10
Detachment of Device or Device Component 8 8
Device Fell 8 8
Unintended System Motion 6 6
Break 5 5
Positioning Failure 5 7
Crack 4 4
Device Dislodged or Dislocated 4 4
Improper or Incorrect Procedure or Method 4 4
Device Handling Problem 4 4
Output Problem 3 3
Positioning Problem 3 3
Material Separation 3 3
Fracture 3 3
Overheating of Device 2 2
Failure to Read Input Signal 2 3
Smoking 2 2
Electrical Shorting 2 2
Misassembly by Users 2 2
Loss of or Failure to Bond 2 2
Connection Problem 2 2
Patient Device Interaction Problem 2 2
Physical Resistance/Sticking 1 1
Wireless Communication Problem 1 1
Misassembled During Installation 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Naturally Worn 1 1
Fitting Problem 1 1
Device Tipped Over 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Communication or Transmission Problem 1 1
Difficult or Delayed Positioning 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Misconnection 1 1
Moisture Damage 1 1
Electrical /Electronic Property Problem 1 2
Entrapment of Device 1 1
Fire 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 100 102
Fall 41 41
Insufficient Information 31 31
Bone Fracture(s) 5 5
Laceration(s) 5 5
Bruise/Contusion 4 4
Abrasion 3 3
Damage to Ligament(s) 2 2
Aspiration/Inhalation 2 2
Burn(s) 2 2
Limb Fracture 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
Vertebral Fracture 2 2
Unintended Extubation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
Stenosis 1 1
Cardiovascular Insufficiency 1 1
Bacterial Infection 1 1
Paraplegia 1 1
Respiratory Insufficiency 1 1
Low Oxygen Saturation 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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