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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
Regulation Description Predictive pulmonary-function value calculator.
Product CodeBTY
Regulation Number 868.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
ERESEARCH TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL GRAPHICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  1.  K181912  Ascent Cardiorespiratory Diagnostic Software
NDD MEDIZITECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
SHAPE MEDICAL SYSTEMS, INC
  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 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
Break 6 6
Smoking 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 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
Device Displays Incorrect Message 2 2
Sparking 2 2
Incorrect Or Inadequate Test Results 2 2
Loose or Intermittent Connection 2 2
Melted 2 2
Failure to Power Up 2 2
Incorrect Software Programming Calculations 2 2
Misconnection 1 1
Overheating of Device 1 1
Incorrect Measurement 1 1
Sensor 1 1
Transformer 1 1
Regulator 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
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 Leak 1 1
Power Problem 1 1
Programming Issue 1 1
Temperature Problem 1 1
Hose 1 1
Patient Data Problem 1 1
Patient Device Interaction Problem 1 1
Application Program 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 Information 4 4
Thromboembolism 1 1
Hypoglycemia 1 1
Red Eye(s) 1 1
Dizziness 1 1
Injury 1 1
Malaise 1 1
Fainting 1 1
Fatigue 1 1
Irritation 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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