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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spirometer, therapeutic (incentive)
Product CodeBWF
Regulation Number 868.5690
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED CIRCULATORY SYSTEM, A WHOLLY OWNED SUBSIDIARY OF
  SUBSTANTIALLY EQUIVALENT 1
D R BURTON HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICA HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDINET SRL
  SUBSTANTIALLY EQUIVALENT 1
RESPINOVA LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 7 7
2018 7 7
2019 16 16
2020 5 5
2021 9 9
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 15 15
Device Operates Differently Than Expected 6 6
Gas Leak 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Break 4 4
Material Separation 4 4
Crack 2 2
Material Fragmentation 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 1 1
Particulates 1 1
Device Dislodged or Dislocated 1 1
Packaging Problem 1 1
Insufficient Information 1 1
Labelling, Instructions for Use or Training Problem 1 1
Contamination 1 1
Vibration 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 25 25
No Clinical Signs, Symptoms or Conditions 9 9
No Known Impact Or Consequence To Patient 3 3
Cardiac Arrest 2 2
Death 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Anemia 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Sepsis 1 1
Congestive Heart Failure 1 1
No Code Available 1 1
Cough 1 1
Injury 1 1
Numbness 1 1
Respiratory Tract Infection 1 1
Choking 1 1
Low Oxygen Saturation 1 1
Sudden Cardiac Death 1 1
Bronchospasm 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD Inc. II Jan-15-2021
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