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TPLC
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show TPLC since
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Device
table, operating-room, electrical
Regulation Description
Operating tables and accessories and operating chairs and accessories.
Product Code
GDC
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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