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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calculator, predicted values, pulmonary function
Product CodeBTY
Regulation Number 868.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
COSMED SRL
  SUBSTANTIALLY EQUIVALENT 1
ERESEARCHTECHNOLOGY GMBH
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL GRAPHICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NDD MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
SHAPE MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VIRTUS TECHNOLOGY APS
  SUBSTANTIALLY EQUIVALENT 1
VITALOGRAPH IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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

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
Overheating of Device 3 3
Failure to Calibrate 3 3
Device Operational Issue 3 3
Connection Problem 3 3
Device Operates Differently Than Expected 2 2
Computer Operating System Problem 2 2
Temperature Problem 2 2
Incorrect Or Inadequate Test Results 2 2
Device Displays Incorrect Message 2 2
Sparking 2 2
Failure to Power Up 2 2
Incorrect Software Programming Calculations 2 2
Loose or Intermittent Connection 2 2
Melted 2 2
Misconnection 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Thermal Decomposition of Device 1 1
Charred 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Computer Software Problem 1 1
Application Program Problem: Dose Calculation Error 1 1
Electrical /Electronic Property Problem 1 1
Grounding Malfunction 1 1
Application Program Problem 1 1
Low Test Results 1 1
Fumes or Vapors 1 1
Defective Device 1 1
Electrical Power Problem 1 1
Environmental Compatibility Problem 1 1
Environmental Particulates 1 1
Gas/Air Leak 1 1
Output Problem 1 1
Power Problem 1 1
Programming Issue 1 1
Patient Data Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 42 42
No Patient Involvement 24 24
No Consequences Or Impact To Patient 16 16
No Clinical Signs, Symptoms or Conditions 5 5
No Information 4 4
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Injury 1 1
Malaise 1 1
Thromboembolism 1 1
Fainting 1 1
Fatigue 1 1
Hypoglycemia 1 1
Irritation 1 1
Red Eye(s) 1 1
Dizziness 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
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