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TPLC
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Device
stethoscope, esophageal, with electrical conductors
Product Code
BZT
Regulation Number
868.1920
Device Class
2
Premarket Reviews
Manufacturer
Decision
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 Information
1
1
No Clinical Signs, Symptoms or Conditions
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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