TPLC - Total Product Life Cycle

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Device	table, operating-room, ac-powered
Regulation Description	Operating tables and accessories and operating chairs and accessories.
Product Code	FQO
Regulation Number	878.4960
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	164	164
Use of Device Problem	107	107
Positioning Failure	92	92
Detachment of Device or Device Component	58	59
Insufficient Information	37	37
Device Fell	31	31
Positioning Problem	30	30
Circuit Failure	23	24
Communication or Transmission Problem	19	20
Smoking	19	19
Fluid/Blood Leak	18	18
Mechanical Problem	18	18
Unintended System Motion	16	16
Electromagnetic Interference	15	15
Device Sensing Problem	14	14
Battery Problem	13	13
Key or Button Unresponsive/not Working	13	13
Device Tipped Over	12	12
No Apparent Adverse Event	12	12
Adverse Event Without Identified Device or Use Problem	11	11
Charging Problem	10	10
Improper or Incorrect Procedure or Method	10	10
Break	10	10
Material Deformation	10	10
Computer Software Problem	10	10
Failure to Interrogate	10	10
Structural Problem	9	9
Patient Device Interaction Problem	9	9
Device Handling Problem	9	9
Failure to Sense	9	9
Fracture	7	7
Difficult or Delayed Positioning	7	7
Mechanical Jam	7	7
Degraded	7	7
Electrical Shorting	6	6
Overheating of Device	6	6
Difficult to Open or Close	6	6
Moisture Damage	6	6
Intermittent Communication Failure	6	6
Leak/Splash	6	6
Therapeutic or Diagnostic Output Failure	5	5
Complete Loss of Power	5	5
Material Split, Cut or Torn	5	5
Device Slipped	5	5
Sharp Edges	5	5
Disconnection	5	5
Device Dislodged or Dislocated	4	4
Naturally Worn	4	4
Electrical /Electronic Property Problem	4	4
Misconnection	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	536	538
Insufficient Information	46	46
Bone Fracture(s)	16	16
Laceration(s)	15	15
Fall	13	13
Abrasion	12	12
Limb Fracture	12	12
Crushing Injury	10	10
Pain	9	9
Unspecified Tissue Injury	8	8
Localized Skin Lesion	5	5
Head Injury	4	4
Bruise/Contusion	4	4
Burn(s)	4	4
Hyperextension	3	3
Unspecified Musculoskeletal problem	2	2
Blister	2	2
Multiple Fractures	2	2
Hemorrhage/Bleeding	2	2
Cardiac Arrest	2	2
Skull Fracture	2	2
Hernia	2	2
Ulcer	2	2
Discomfort	2	2
Joint Dislocation	2	2
Skin Tears	2	2
Electric Shock	1	1
Bowel Perforation	1	1
No Information	1	1
Injury	1	1
Hematoma	1	1
Low Blood Pressure/ Hypotension	1	1
Swelling/ Edema	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Getinge Group Logistics America, LLC	II	Mar-23-2021
2	Getinge Usa Sales Inc	II	Nov-14-2024
3	Getinge Usa Sales Inc	II	Jul-05-2024
4	Getinge Usa Sales Inc	II	Oct-04-2023
5	Getinge Usa Sales Inc	II	Nov-15-2022
6	IHB OPERATIONS B.V.	II	Apr-23-2025
7	IHB OPERATIONS B.V.	II	Dec-01-2023
8	MAQUET GMBH	II	Aug-22-2025
9	Skytron, Div. The KMW Group, Inc	II	Jun-30-2022
10	Skytron, Div. The KMW Group, Inc	II	Jun-15-2021
11	Stryker Communications	II	Mar-24-2021