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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device chair, geriatric
Product CodeFRJ
Regulation Number 880.6140
Device Class 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 2 2
2016 1 1
2018 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2 2
Unstable 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Unintended Arm Motion 1 1
Break 1 1
Thermal Decomposition of Device 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Tipped Over 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hip Fracture 3 3
Skin Tears 1 1
No Code Available 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Fall 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Swelling 1 1
No Consequences Or Impact To Patient 1 1
Complaint, Ill-Defined 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom, Inc. II Feb-23-2016
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