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	163	163
Use of Device Problem	95	95
Positioning Failure	64	64
Detachment of Device or Device Component	58	58
Insufficient Information	49	49
Mechanical Problem	30	30
Improper or Incorrect Procedure or Method	29	29
Positioning Problem	26	26
Device Fell	26	26
Electromagnetic Interference	23	23
Adverse Event Without Identified Device or Use Problem	22	22
Device Tipped Over	21	21
Unintended System Motion	20	20
Smoking	19	19
Communication or Transmission Problem	19	19
Fluid/Blood Leak	18	18
Device Sensing Problem	16	16
Circuit Failure	16	16
Break	14	14
Battery Problem	13	13
No Apparent Adverse Event	12	12
Device Handling Problem	11	11
Electrical Shorting	8	8
Difficult or Delayed Positioning	8	8
Key or Button Unresponsive/not Working	7	7
Naturally Worn	7	7
Sharp Edges	7	7
Structural Problem	7	7
Fire	7	7
Self-Activation or Keying	7	7
Unintended Collision	6	6
Noise, Audible	6	6
Sparking	6	6
Electrical /Electronic Property Problem	6	6
Disconnection	6	6
Device Slipped	6	6
Fracture	6	6
Charging Problem	6	6
Device Emits Odor	6	6
Patient Device Interaction Problem	6	6
Complete Loss of Power	6	6
Material Split, Cut or Torn	5	5
Physical Resistance/Sticking	5	5
Therapeutic or Diagnostic Output Failure	5	5
Moisture Damage	5	5
Intermittent Communication Failure	5	5
Overheating of Device	5	5
Mechanical Jam	4	4
Failure to Interrogate	4	4
Protective Measures Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	425	425
No Known Impact Or Consequence To Patient	69	69
Insufficient Information	48	48
No Consequences Or Impact To Patient	46	46
Laceration(s)	30	30
Injury	26	26
Fall	19	19
Bone Fracture(s)	16	16
Electric Shock	11	11
Abrasion	11	11
Pain	8	8
No Information	7	7
Unspecified Tissue Injury	6	6
Limb Fracture	6	6
Head Injury	6	6
Bruise/Contusion	5	5
Burn(s)	5	5
Crushing Injury	5	5
No Code Available	5	5
Death	5	5
Localized Skin Lesion	3	3
No Patient Involvement	3	3
Hematoma	3	3
Hyperextension	3	3
Tooth Fracture	2	2
Cardiac Arrest	2	2
Multiple Fractures	2	2
Muscle Weakness	2	2
Nerve Damage	2	2
Discomfort	2	2
Unspecified Musculoskeletal problem	2	2
Nausea	2	2
Ulcer	2	2
Skin Tears	2	2
Low Blood Pressure/ Hypotension	2	2
Edema	1	1
Hematuria	1	1
Tissue Damage	1	1
Hemorrhage/Bleeding	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Patient Problem/Medical Problem	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	Jul-05-2024
3	Getinge Usa Sales Inc	II	Oct-04-2023
4	Getinge Usa Sales Inc	II	Nov-15-2022
5	IHB OPERATIONS B.V.	II	Dec-01-2023
6	Maquet Cardiovascular Us Sales, Llc	II	Oct-20-2020
7	Skytron, Div. The KMW Group, Inc	II	Jun-30-2022
8	Skytron, Div. The KMW Group, Inc	II	Jun-15-2021
9	Skytron, Div. The KMW Group, Inc	II	Mar-25-2020
10	Stryker Communications	II	Mar-24-2021