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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
2020 253 253
2021 259 259
2022 57 57
2023 62 62
2024 91 91
2025 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Unstable 119 119
Unintended Movement 115 115
Physical Resistance/Sticking 78 78
Positioning Problem 44 44
Leak/Splash 37 37
Positioning Failure 34 34
Battery Problem 26 26
Overheating of Device 25 25
Operating System Becomes Nonfunctional 25 25
Material Too Rigid or Stiff 23 23
Failure to Power Up 22 22
Key or Button Unresponsive/not Working 22 22
Fluid/Blood Leak 21 21
Mechanical Jam 21 21
Noise, Audible 20 20
No Apparent Adverse Event 19 19
Mechanical Problem 18 18
Unintended System Motion 16 16
Decrease in Pressure 13 13
Smoking 12 12
Device Fell 10 10
Fire 9 9
Break 9 9
Use of Device Problem 9 9
Insufficient Information 8 8
Failure to Charge 6 6
Fracture 5 5
Material Deformation 5 5
Crack 5 5
Defective Component 5 5
Device Slipped 5 5
Electrical Shorting 4 4
Device Dislodged or Dislocated 4 4
Sparking 4 4
Electrical /Electronic Property Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Difficult or Delayed Positioning 4 4
Power Problem 4 4
Connection Problem 3 3
Self-Activation or Keying 3 3
Loss of Power 3 3
Output Problem 3 3
Pressure Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Appropriate Term/Code Not Available 3 3
Device Handling Problem 3 3
Compatibility Problem 2 2
Failure of Device to Self-Test 2 2
Loose or Intermittent Connection 2 2
Detachment of Device or Device Component 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 511 511
No Patient Involvement 120 120
No Known Impact Or Consequence To Patient 61 61
Insufficient Information 13 13
No Information 12 12
No Consequences Or Impact To Patient 8 8
Bruise/Contusion 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Laceration(s) 4 4
Liver Laceration(s) 4 4
Numbness 3 3
Bone Fracture(s) 3 3
Nerve Damage 3 3
Hyperextension 2 2
Abdominal Distention 2 2
Brain Injury 1 1
Injury 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Wound Dehiscence 1 1
Burn(s) 1 1
Cellulitis 1 1
Crushing Injury 1 1
Fall 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Skin Burning Sensation 1 1
Unspecified Tissue Injury 1 1
Pain 1 1
Perforation 1 1
Rupture 1 1
No Code Available 1 1
Heart Failure/Congestive Heart Failure 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 Baxter Healthcare Corporation II Aug-06-2024
4 Baxter Healthcare Corporation II Jul-07-2023
5 Baxter Healthcare Corporation II Nov-03-2022
6 Mizuho America, Inc. II Dec-14-2020
7 Mizuho OSI II Mar-23-2021
8 Skytron, LLC II Aug-28-2023
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