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	167	167
Use of Device Problem	118	118
Positioning Failure	89	89
Detachment of Device or Device Component	56	56
Insufficient Information	49	49
Positioning Problem	31	31
Device Fell	30	30
Improper or Incorrect Procedure or Method	27	27
Circuit Failure	23	23
Electromagnetic Interference	23	23
Unintended System Motion	19	19
Mechanical Problem	19	19
Communication or Transmission Problem	19	19
Adverse Event Without Identified Device or Use Problem	18	18
Fluid/Blood Leak	16	16
Device Tipped Over	16	16
Smoking	15	15
Battery Problem	15	15
Device Sensing Problem	14	14
Break	12	12
No Apparent Adverse Event	12	12
Device Handling Problem	12	12
Key or Button Unresponsive/not Working	12	12
Computer Software Problem	10	10
Material Deformation	10	10
Failure to Interrogate	10	10
Charging Problem	10	10
Failure to Sense	9	9
Structural Problem	9	9
Patient Device Interaction Problem	9	9
Mechanical Jam	7	7
Complete Loss of Power	7	7
Difficult or Delayed Positioning	7	7
Sharp Edges	7	7
Degraded	7	7
Intermittent Communication Failure	6	6
Difficult to Open or Close	6	6
Overheating of Device	6	6
Fracture	6	6
Electrical Shorting	6	6
Moisture Damage	6	6
Disconnection	6	6
Therapeutic or Diagnostic Output Failure	5	5
Material Split, Cut or Torn	5	5
Electrical Overstress	5	5
Device Slipped	5	5
Unintended Electrical Shock	5	5
Electrical /Electronic Property Problem	5	5
Leak/Splash	5	5
Device Emits Odor	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	527	527
Insufficient Information	49	49
Laceration(s)	30	30
No Consequences Or Impact To Patient	21	21
Bone Fracture(s)	16	16
Fall	16	16
Abrasion	12	12
No Known Impact Or Consequence To Patient	10	10
Injury	10	10
Limb Fracture	10	10
Crushing Injury	8	8
Pain	8	8
Burn(s)	7	7
Head Injury	6	6
Unspecified Tissue Injury	6	6
No Information	5	5
Localized Skin Lesion	5	5
Bruise/Contusion	5	5
Electric Shock	4	4
Hyperextension	3	3
Hemorrhage/Bleeding	3	3
Death	2	2
Nausea	2	2
No Code Available	2	2
Skull Fracture	2	2
Unspecified Musculoskeletal problem	2	2
Muscle Weakness	2	2
Multiple Fractures	2	2
Blister	2	2
Cardiac Arrest	2	2
Nerve Damage	2	2
Hernia	2	2
Discomfort	2	2
Ulcer	2	2
Skin Tears	2	2
Low Blood Pressure/ Hypotension	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hematoma	1	1
No Patient Involvement	1	1
Device Embedded In Tissue or Plaque	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	Maquet Cardiovascular Us Sales, Llc	II	Oct-20-2020
10	Skytron, Div. The KMW Group, Inc	II	Jun-30-2022
11	Skytron, Div. The KMW Group, Inc	II	Jun-15-2021
12	Skytron, Div. The KMW Group, Inc	II	Mar-25-2020
13	Stryker Communications	II	Mar-24-2021