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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device exerciser, powered
Product CodeBXB
Regulation Number 890.5380
Device Class 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 6 6
2016 6 6
2017 4 4
2018 2 2
2019 2 2
2021 2 2
2023 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Mechanics Altered 4 4
Insufficient Information 4 4
Use of Device Problem 4 4
Physical Resistance/Sticking 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Sparking 2 2
Failure to Power Up 2 2
Detachment Of Device Component 2 2
Fire 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Loss of Power 1 1
Material Separation 1 1
Device Inoperable 1 1
Calibration Error 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Fell 1 1
Complete Loss of Power 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Bone Fracture(s) 6 6
Laceration(s) 4 4
Injury 4 4
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 3 3
Skin Tears 2 2
Swelling 2 2
Pain 2 2
Bruise/Contusion 2 2
Fall 2 2
Hemorrhage/Bleeding 2 2
Burn(s) 1 1
Emotional Changes 1 1
Head Injury 1 1
Headache 1 1
Hematoma 1 1
Perforation 1 1
Shock 1 1
No Consequences Or Impact To Patient 1 1
Physical Entrapment 1 1
Disability 1 1
Respiratory Acidosis 1 1
Ambulation Difficulties 1 1
No Patient Involvement 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accelerated Care Plus Corporation II Jul-31-2013
2 Alter-G, Incorporated II Aug-16-2011
3 BioMotion Medical Systems, LLC II Dec-20-2012
4 Hocoma AG II Jan-07-2010
5 MOTEK MEDICAL B.V. II May-27-2020
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