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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, operating-room, pneumatic
Product CodeFWW
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2018 2 2
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 11 11
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Sparking 1 1
Device Fell 1 1
Mechanical Problem 1 1
Positioning Problem 1 1
Device Emits Odor 1 1
Self-Activation or Keying 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 7 7
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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