TPLC - Total Product Life Cycle

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Device	table, operating-room, ac-powered
Product Code	FQO
Regulation Number	878.4960
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	150	150
Use of Device Problem	107	107
Positioning Failure	71	71
Insufficient Information	48	48
Detachment of Device or Device Component	45	45
Positioning Problem	30	30
Improper or Incorrect Procedure or Method	26	26
Device Fell	25	25
Electromagnetic Interference	23	23
Circuit Failure	19	19
Communication or Transmission Problem	18	18
Fluid/Blood Leak	16	16
Unintended System Motion	16	16
Battery Problem	15	15
Device Tipped Over	15	15
Mechanical Problem	14	14
Device Sensing Problem	14	14
No Apparent Adverse Event	12	12
Adverse Event Without Identified Device or Use Problem	12	12
Smoking	12	12
Break	11	11
Device Handling Problem	11	11
Computer Software Problem	9	9
Structural Problem	9	9
Difficult or Delayed Positioning	8	8
Failure to Sense	8	8
Charging Problem	8	8
Patient Device Interaction Problem	7	7
Key or Button Unresponsive/not Working	7	7
Degraded	7	7
Naturally Worn	7	7
Sharp Edges	7	7
Failure to Interrogate	7	7
Moisture Damage	6	6
Electrical Shorting	6	6
Fracture	6	6
Complete Loss of Power	6	6
Intermittent Communication Failure	6	6
Device Emits Odor	5	5
Overheating of Device	5	5
Electrical /Electronic Property Problem	5	5
Disconnection	5	5
Electrical Overstress	5	5
Material Split, Cut or Torn	5	5
Fire	5	5
Therapeutic or Diagnostic Output Failure	4	4
Unintended Collision	4	4
Failure to Charge	4	4
Mechanical Jam	4	4
Difficult to Open or Close	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	454	454
Insufficient Information	49	49
Laceration(s)	32	32
No Consequences Or Impact To Patient	21	21
Bone Fracture(s)	15	15
Fall	13	13
Abrasion	11	11
No Known Impact Or Consequence To Patient	10	10
Injury	10	10
Limb Fracture	8	8
Burn(s)	7	7
Pain	7	7
Head Injury	6	6
Crushing Injury	6	6
Unspecified Tissue Injury	6	6
Bruise/Contusion	6	6
No Information	5	5
Electric Shock	3	3
Hematoma	3	3
Localized Skin Lesion	3	3
Hyperextension	3	3
Death	2	2
No Code Available	2	2
Nausea	2	2
Unspecified Musculoskeletal problem	2	2
Skull Fracture	2	2
Muscle Weakness	2	2
Multiple Fractures	2	2
Tooth Fracture	2	2
Cardiac Arrest	2	2
Nerve Damage	2	2
Discomfort	2	2
Skin Tears	2	2
Ulcer	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