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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, operating-room, electrical
Regulation Description Operating tables and accessories and operating chairs and accessories.
Product CodeGDC
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2021 259 259
2022 57 57
2023 62 62
2024 91 91
2025 101 101
2026 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 150 150
Unstable 100 100
Physical Resistance/Sticking 48 48
Key or Button Unresponsive/not Working 40 40
Leak/Splash 26 26
Operating System Becomes Nonfunctional 25 25
Overheating of Device 23 23
Battery Problem 23 23
Unintended System Motion 20 20
No Apparent Adverse Event 19 19
Device Fell 18 18
Failure to Power Up 17 17
Noise, Audible 16 16
Mechanical Problem 12 12
Smoking 10 10
Material Too Rigid or Stiff 10 10
Mechanical Jam 9 9
Positioning Problem 9 9
Use of Device Problem 7 7
Insufficient Device Problem Information 7 7
Decrease in Pressure 7 7
Device Slipped 6 6
Fire 6 6
Positioning Failure 6 6
Difficult or Delayed Positioning 6 6
Electrical /Electronic Property Problem 5 5
Break 5 5
Device Dislodged or Dislocated 5 5
Fracture 5 5
Defective Component 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Pressure Problem 4 4
Electrical Shorting 4 4
Unintended Collision 3 3
Fluid/Blood Leak 3 3
Loss of Power 3 3
Power Problem 3 3
Appropriate Device Problem Term/Code Not Available 3 3
Detachment of Device or Device Component 3 3
Device Handling Problem 3 3
Material Deformation 3 3
Unexpected Shutdown 3 3
Sparking 3 3
Failure to Charge 3 3
Material Integrity Problem 2 2
Activation Failure 2 2
Explosion 2 2
Crack 2 2
Connection Problem 2 2
Complete Loss of Power 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 567 567
Insufficient Information 13 13
Laceration(s) 5 5
Bruise/Contusion 5 5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 5 5
Bone Fracture(s) 4 4
Fall 4 4
Liver Laceration(s) 4 4
Nerve Damage 3 3
Numbness 3 3
Hyperextension 3 3
Abdominal Distention 2 2
Unspecified Tissue Injury 2 2
Electric Shock 1 1
Brain Injury 1 1
Hematoma 1 1
Crushing Injury 1 1
Burn, Thermal 1 1
Burn(s) 1 1
Neck Pain 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Pain 1 1
Heart Failure/Congestive Heart Failure 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jul-01-2026
2 Baxter Healthcare Corporation II Mar-21-2025
3 Baxter Healthcare Corporation II Oct-24-2024
4 Baxter Healthcare Corporation II Aug-06-2024
5 Baxter Healthcare Corporation II Jul-07-2023
6 Baxter Healthcare Corporation II Nov-03-2022
7 Mizuho OSI II Mar-23-2021
8 Skytron, LLC II Aug-28-2023
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