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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
Product CodeBZT
Regulation Number 868.1920
Device Class 2


Premarket Reviews
ManufacturerDecision
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
STARBOARD MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
TRUER MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2017 2 2
2018 1 1
2019 3 3
2021 3 3
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Incorrect Measurement 3 3
Output Problem 3 3
Positioning Problem 1 1
Unintended Movement 1 1
Unable to Obtain Readings 1 1
Erratic or Intermittent Display 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Sensing Intermittently 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Defective Component 1 1
High Readings 1 1
Low Readings 1 1
Improper Device Output 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Information 1 1
Alteration in Body Temperature 1 1
Alteration In Body Temperature 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cincinnati Sub-Zero Products Inc II Jan-11-2012
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