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 Code	GDC
Regulation Number	878.4960
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	135	135
Unstable	95	95
Physical Resistance/Sticking	49	49
Key or Button Unresponsive/not Working	33	33
Operating System Becomes Nonfunctional	25	25
Leak/Splash	24	24
Overheating of Device	23	23
Battery Problem	23	23
No Apparent Adverse Event	19	19
Noise, Audible	17	17
Unintended System Motion	17	17
Failure to Power Up	17	17
Device Fell	13	13
Mechanical Problem	12	12
Smoking	10	10
Material Too Rigid or Stiff	10	10
Mechanical Jam	8	8
Fire	8	8
Positioning Problem	8	8
Use of Device Problem	8	8
Insufficient Information	7	7
Decrease in Pressure	7	7
Device Slipped	6	6
Break	6	6
Difficult or Delayed Positioning	6	6
Device Dislodged or Dislocated	5	5
Fracture	5	5
Defective Component	5	5
Sparking	4	4
Electrical /Electronic Property Problem	4	4
Pressure Problem	4	4
Power Problem	4	4
Electrical Shorting	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Fluid/Blood Leak	3	3
Loss of Power	3	3
Appropriate Term/Code Not Available	3	3
Device Handling Problem	3	3
Material Deformation	3	3
Positioning Failure	3	3
Crack	3	3
Failure to Charge	3	3
Material Integrity Problem	2	2
Detachment of Device or Device Component	2	2
Output Problem	2	2
Unexpected Shutdown	2	2
Connection Problem	2	2
Material Split, Cut or Torn	2	2
Compatibility Problem	2	2
Loose or Intermittent Connection	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	523	523
Insufficient Information	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Bruise/Contusion	5	5
Laceration(s)	4	4
Liver Laceration(s)	4	4
Bone Fracture(s)	3	3
Nerve Damage	3	3
Numbness	3	3
Fall	3	3
Abdominal Distention	2	2
Hyperextension	2	2
Unspecified Tissue Injury	2	2
Electric Shock	1	1
Brain Injury	1	1
Hematoma	1	1
Burn, Thermal	1	1
Crushing Injury	1	1
Burn(s)	1	1
Neck Pain	1	1
Pain	1	1
Heart Failure/Congestive Heart Failure	1	1
Hemorrhage/Bleeding	1	1
Skin Burning Sensation	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 OSI	II	Mar-23-2021
7	Skytron, LLC	II	Aug-28-2023