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	159	159
Use of Device Problem	108	108
Positioning Failure	93	93
Insufficient Device Problem Information	77	77
Detachment of Device or Device Component	51	52
Device Fell	31	31
Positioning Problem	29	29
Circuit Failure	23	24
Communication or Transmission Problem	20	21
Fluid/Blood Leak	17	17
Device Tipped Over	15	15
Electromagnetic Interference	15	15
Device Sensing Problem	14	14
Unintended System Motion	14	14
Battery Problem	13	13
Smoking	13	13
Mechanical Problem	12	12
No Apparent Adverse Event	12	12
Adverse Event Without Identified Device or Use Problem	11	11
Material Deformation	10	10
Improper or Incorrect Procedure or Method	10	10
Computer Software Problem	10	10
Key or Button Unresponsive/not Working	10	10
Charging Problem	10	10
Failure to Interrogate	10	10
Device Handling Problem	9	9
Failure to Sense	9	9
Structural Problem	9	9
Break	8	8
Fracture	7	7
Patient Device Interaction Problem	7	7
Difficult or Delayed Positioning	7	7
Degraded	7	7
Difficult to Open or Close	7	7
Moisture Damage	6	6
Intermittent Communication Failure	6	6
Electrical Shorting	6	6
Overheating of Device	6	6
Mechanical Jam	6	6
Material Split, Cut or Torn	5	5
Sharp Edges	5	5
Electrical /Electronic Property Problem	5	5
Leak/Splash	5	5
Complete Loss of Power	5	5
Disconnection	5	5
Misconnection	4	4
Unintended Collision	4	4
Failure to Charge	4	4
Electrical Overstress	4	4
Fire	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	562	564
Insufficient Information	47	47
Pressure Sore/Ulcer	40	40
Bone Fracture(s)	16	16
Laceration(s)	15	15
Crushing Injury	14	14
Abrasion	13	13
Fall	13	13
Limb Fracture	12	12
Pain	11	11
Unspecified Tissue Injury	10	10
Bruise/Contusion	6	6
Localized Skin Lesion	5	5
Head Injury	4	4
Burn(s)	4	4
Hyperextension	3	3
Ulcer	2	2
Skin Tears	2	2
Tooth Loss	2	2
Blister	2	2
Skull Fracture	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Joint Dislocation	2	2
Hernia	2	2
Unspecified Musculoskeletal problem	2	2
Multiple Fractures	2	2
Cardiac Arrest	2	2
Discomfort	2	2
Respiratory Arrest	1	1
Low Blood Pressure/ Hypotension	1	1
Bowel Perforation	1	1
Injury	1	1
Cartilage damage	1	1
Swelling/ Edema	1	1
Hematoma	1	1
Electric Shock	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
No Information	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