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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 oximeter, ear
Product CodeDPZ
Regulation Number 870.2710
Device Class 2

MDR Year MDR Reports MDR Events
2017 4 4
2018 4 4
2019 2 2
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Alarm 2 2
Incorrect Measurement 2 2
Device Displays Incorrect Message 2 2
Device Operates Differently Than Expected 1 1
Inappropriate or Unexpected Reset 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
Nonstandard Device 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Use of Device Problem 1 1
High Readings 1 1
Low Readings 1 1
No Audible Alarm 1 1
Alarm Not Visible 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
Burn(s) 2 2
Death 1 1
Respiratory Failure 1 1
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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