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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stethoscope, esophageal, with electrical conductors
Regulation Description Esophageal stethoscope with electrical conductors.
Product CodeBZT
Regulation Number 868.1920
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 1 1
2024 3 3
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Compatibility Problem 1 1
Sensing Intermittently 1 1
Unintended Movement 1 1
Positioning Problem 1 1
High Readings 1 1
Device Sensing Problem 1 1
Incorrect Interpretation of Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Laceration(s) of Esophagus 1 1
Alteration in Body Temperature 1 1

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