TPLC - Total Product Life Cycle

• Device: table, examination, medical, powered
• Product Code: LGX
• Regulation Number: 878.4960
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	4	4
2015	4	4
2016	1	1
2017	10	10
2018	1	1
2019	1	1
2020	2	2
2021	1	1
2022	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	3	3
Unintended System Motion	3	3
Unintended Movement	3	3
Device Issue	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Power Problem	2	2
Break	2	2
Collapse	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Electrical /Electronic Property Problem	1	1
Overheating of Device	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Sticking	1	1
Unstable	1	1
Component Missing	1	1
Device Operates Differently Than Expected	1	1
Noise, Audible	1	1
Physical Resistance/Sticking	1	1
Premature Discharge of Battery	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	12	12
Seizures	2	2
No Consequences Or Impact To Patient	2	2
Bruise/Contusion	2	2
Fainting	1	1
Fall	1	1
Discomfort	1	1
Injury	1	1
Fracture, Arm	1	1
Loss of consciousness	1	1
Electric Shock	1	1
Not Applicable	1	1
No Information	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Brewer Company, LLC	II	Jul-24-2018
2	Heritage Medical Products, Inc.	II	Nov-08-2019
3	Maquet Cardiovascular Us Sales, Llc	II	Jun-04-2019
4	Maquet Cardiovascular Us Sales, Llc	II	Jul-01-2013
5	Medical Positioning Inc	II	Aug-13-2014
6	Medical Positioning Inc	II	Mar-15-2012
7	Oakworks Inc	II	Jan-13-2024
8	Oakworks Inc	II	Aug-25-2021