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TPLC
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Device
calculator, predicted values, pulmonary function
Product Code
BTY
Regulation Number
868.1890
Device Class
2
Premarket Reviews
Manufacturer
Decision
CAREFUSION GERMANY 234 GMBH
SUBSTANTIALLY EQUIVALENT
3
COSMED SRL
SUBSTANTIALLY EQUIVALENT
1
ERESEARCHTECHNOLOGY GMBH
SUBSTANTIALLY EQUIVALENT
3
GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MEDICAL GRAPHICS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NDD MEDIZINTECHNIK AG
SUBSTANTIALLY EQUIVALENT
1
NDD MEDIZITECHNIK AG
SUBSTANTIALLY EQUIVALENT
2
SHAPE MEDICAL SYSTEMS, INC
SUBSTANTIALLY EQUIVALENT
2
VIRTUS TECHNOLOGY APS
SUBSTANTIALLY EQUIVALENT
1
VITALOGRAPH IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
51
51
2016
24
24
2017
9
9
2018
5
5
2019
3
3
2020
3
3
2021
2
2
2022
2
2
2023
1
1
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
27
27
Device Stops Intermittently
11
11
Calibration Problem
8
8
Smoking
7
7
Break
6
6
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Device Operational Issue
3
3
Failure to Calibrate
3
3
Overheating of Device
3
3
Connection Problem
3
3
Battery Problem
2
2
Sparking
2
2
Temperature Problem
2
2
Loose or Intermittent Connection
2
2
Incorrect Software Programming Calculations
2
2
Device Displays Incorrect Message
2
2
Melted
2
2
Device Operates Differently Than Expected
2
2
Computer Operating System Problem
2
2
Failure to Power Up
2
2
Incorrect Or Inadequate Test Results
2
2
Defective Device
1
1
Patient Data Problem
1
1
Grounding Malfunction
1
1
Electrical Power Problem
1
1
Application Program Problem
1
1
Computer Software Problem
1
1
Electrical /Electronic Property Problem
1
1
Power Problem
1
1
Environmental Compatibility Problem
1
1
Component Falling
1
1
Low Test Results
1
1
Detachment Of Device Component
1
1
Misconnection
1
1
Fumes or Vapors
1
1
Leak/Splash
1
1
Gas/Air Leak
1
1
Charred
1
1
Output Problem
1
1
Mechanical Problem
1
1
Patient Device Interaction Problem
1
1
Thermal Decomposition of Device
1
1
Application Program Problem: Dose Calculation Error
1
1
Incorrect Measurement
1
1
Environmental Particulates
1
1
Programming Issue
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
43
43
No Patient Involvement
24
24
No Consequences Or Impact To Patient
16
16
No Clinical Signs, Symptoms or Conditions
7
7
No Information
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Red Eye(s)
1
1
Fatigue
1
1
Dizziness
1
1
Malaise
1
1
Irritation
1
1
Injury
1
1
Insufficient Information
1
1
Hypoglycemia
1
1
Thromboembolism
1
1
Fainting
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
NDDd Medical Technologies, Inc.
II
Dec-03-2019
2
Shape Medical Systems, Inc
II
Feb-05-2015
3
Shape Medical Systems, Inc
II
Jul-14-2014
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