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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device scale, patient
Product CodeFRW
Regulation Number 880.2720
Device Class 1

MDR Year MDR Reports MDR Events
2017 5 5
2018 1 1
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 3 3
Device Inoperable 1 1
Calibration Problem 1 1
Detachment of Device or Device Component 1 1
Device Operational Issue 1 1
Material Integrity Problem 1 1
Naturally Worn 1 1
Break 1 1
Component Falling 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
False Reading From Device Non-Compliance 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Code Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 1 1
Non specific EKG/ECG Changes 1 1
No Consequences Or Impact To Patient 1 1
Brain Injury 1 1

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