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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device washer of body waste receptacles
Product CodeFLH
Regulation Number 880.6800
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 5 5
2021 5 5
2022 6 6
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 9 9
Use of Device Problem 5 5
Fluid/Blood Leak 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Emits Odor 2 2
Break 2 2
Defective Component 2 2
Electrical Shorting 2 2
Failure to Auto Stop 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Electrical /Electronic Property Problem 1 1
Material Frayed 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Patient Involvement 8 8
Sore Throat 4 4
Electric Shock 2 2
Fall 2 2
Insufficient Information 2 2
Laceration(s) 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
No Known Impact Or Consequence To Patient 1 1
Blister 1 1

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