TPLC - Total Product Life Cycle

• Device: treadmill, powered
• Product Code: IOL
• Regulation Number: 890.5380
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	6	6
2015	12	12
2016	1	1
2017	4	4
2018	4	4
2019	6	6
2020	1	1
2021	1	1
2022	1	1
2023	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operates Differently Than Expected	11	11
Unintended Movement	5	5
Self-Activation or Keying	4	4
Mechanical Problem	3	3
Protective Measures Problem	3	3
Unintended System Motion	2	2
Improper or Incorrect Procedure or Method	2	2
Failure to Shut Off	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Operating System Becomes Nonfunctional	1	1
Output Problem	1	1
Programming Issue	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Insufficient Information	1	1
Device Stops Intermittently	1	1
Use of Device Problem	1	1
Device Emits Odor	1	1
Break	1	1
Calibration Error	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	14	14
Fall	13	13
No Consequences Or Impact To Patient	5	5
Abrasion	5	5
No Patient Involvement	3	3
Injury	3	3
Bone Fracture(s)	2	2
No Clinical Signs, Symptoms or Conditions	2	2
No Information	1	1
Insufficient Information	1	1
Discomfort	1	1
Pain	1	1
Loss of Range of Motion	1	1
Fracture, Arm	1	1
Arthralgia	1	1
Joint Dislocation	1	1
Loss of consciousness	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	AlterG, Incorporated	II	Mar-04-2014
2	Cardiac Science Corporation	II	Jun-04-2010
3	Full Vision Inc	II	Jun-30-2023
4	Full Vision Inc	II	Dec-03-2022
5	GE Healthcare	II	Jun-22-2015
6	GE Healthcare	II	Mar-17-2015
7	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	II	Jul-16-2018