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	157	157
Use of Device Problem	113	113
Positioning Failure	76	76
Detachment of Device or Device Component	48	48
Insufficient Information	48	48
Positioning Problem	31	31
Improper or Incorrect Procedure or Method	26	26
Device Fell	25	25
Electromagnetic Interference	23	23
Circuit Failure	20	20
Communication or Transmission Problem	19	19
Fluid/Blood Leak	16	16
Unintended System Motion	16	16
Device Tipped Over	15	15
Battery Problem	15	15
Device Sensing Problem	14	14
Mechanical Problem	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Smoking	13	13
No Apparent Adverse Event	12	12
Break	11	11
Device Handling Problem	11	11
Computer Software Problem	9	9
Charging Problem	9	9
Structural Problem	9	9
Patient Device Interaction Problem	9	9
Difficult or Delayed Positioning	8	8
Failure to Sense	8	8
Key or Button Unresponsive/not Working	8	8
Naturally Worn	7	7
Sharp Edges	7	7
Failure to Interrogate	7	7
Degraded	7	7
Intermittent Communication Failure	6	6
Complete Loss of Power	6	6
Fracture	6	6
Electrical Shorting	6	6
Moisture Damage	6	6
Disconnection	6	6
Electrical Overstress	5	5
Electrical /Electronic Property Problem	5	5
Difficult to Open or Close	5	5
Overheating of Device	5	5
Device Emits Odor	5	5
Fire	5	5
Material Split, Cut or Torn	5	5
Unintended Collision	4	4
Failure to Charge	4	4
Mechanical Jam	4	4
Therapeutic or Diagnostic Output Failure	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	472	472
Insufficient Information	49	49
Laceration(s)	32	32
No Consequences Or Impact To Patient	21	21
Bone Fracture(s)	16	16
Fall	13	13
Abrasion	12	12
No Known Impact Or Consequence To Patient	10	10
Injury	10	10
Limb Fracture	8	8
Burn(s)	7	7
Pain	7	7
Bruise/Contusion	7	7
Head Injury	6	6
Crushing Injury	6	6
Unspecified Tissue Injury	6	6
No Information	5	5
Ulcer	4	4
Electric Shock	3	3
Hematoma	3	3
Localized Skin Lesion	3	3
Hyperextension	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
Tooth Fracture	2	2
Blister	2	2
Cardiac Arrest	2	2
Nerve Damage	2	2
Discomfort	2	2
Skin Tears	2	2
Low Blood Pressure/ Hypotension	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Patient Involvement	1	1
Hemorrhage/Bleeding	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	Dec-01-2023
7	Maquet Cardiovascular Us Sales, Llc	II	Oct-20-2020
8	Skytron, Div. The KMW Group, Inc	II	Jun-30-2022
9	Skytron, Div. The KMW Group, Inc	II	Jun-15-2021
10	Skytron, Div. The KMW Group, Inc	II	Mar-25-2020
11	Stryker Communications	II	Mar-24-2021