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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter, ear
Product CodeDPZ
Regulation Number 870.2710
Device Class 2

MDR Year MDR Reports MDR Events
2018 4 4
2019 2 2
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 2 2
Nonstandard Device 1 1
Use of Device Problem 1 1
High Readings 1 1
Low Readings 1 1
Device Displays Incorrect Message 1 1
Device Operates Differently Than Expected 1 1
Compatibility Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
Burn(s) 2 2
Superficial (First Degree) Burn 1 1
No Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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