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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scale, patient
Regulation Description Patient scale.
Product CodeFRW
Regulation Number 880.2720
Device Class 1

MDR Year MDR Reports MDR Events
2015 5 5
2016 1 1
2017 5 5
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 2 2
Material Integrity Problem 2 2
Scale 2 2
Overheating of Device 2 2
Device Operates Differently Than Expected 2 2
Device Operational Issue 1 1
Wheel 1 1
Device Tipped Over 1 1
Calibration Problem 1 1
Break 1 1
No Display/Image 1 1
False Reading From Device Non-Compliance 1 1
Melted 1 1
Device Emits Odor 1 1
Unintended Movement 1 1
Component Falling 1 1
Loose or Intermittent Connection 1 1
Device Maintenance Issue 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Device Sensing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Code Available 2 2
Death 1 1
Head Injury 1 1
Brain Injury 1 1
No Information 1 1
Non specific EKG/ECG Changes 1 1
Fall 1 1
No Consequences Or Impact To Patient 1 1
Hip Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Seca II Mar-03-2020
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