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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 table, operating-room, pneumatic
Product CodeFWW
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 2 2
2021 1 1
2022 6 6
2023 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 10 10
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 2 2
Sparking 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Problem 1 1
Device Emits Odor 1 1
Positioning Problem 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
No Known Impact Or Consequence To Patient 5 5
Head Injury 1 1
Fall 1 1
Pain 1 1
Skin Tears 1 1
No Consequences Or Impact To Patient 1 1

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