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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
ACTEGY LTD
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED CIRCULATORY SYSTEM, A WHOLLY OWNED SUBSIDIARY OF
  SUBSTANTIALLY EQUIVALENT 1
BESMED HEALTH BUSINESS CORP.
  SUBSTANTIALLY EQUIVALENT 1
BESMED HEALTH BUSINESS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
D R BURTON HEALTHCARE LLC
  SUBSTANTIALLY EQUIVALENT 1
D R BURTON HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENCHANT TEK CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH
  SUBSTANTIALLY EQUIVALENT 1
LUNG TRAINERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICA HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL ACOUSTICS
  SUBSTANTIALLY EQUIVALENT 1
MEDINET SRL
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARI RESPIRATORY EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
PEEP MEDICAL LLC DBA GO2 DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPINOVA LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
TRUDELL MEDICAL INTL.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 16 16
2016 6 6
2017 7 7
2018 7 7
2019 16 16
2020 5 5
2021 9 9
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 15 15
Leak/Splash 13 13
Device Operates Differently Than Expected 9 9
Adverse Event Without Identified Device or Use Problem 5 5
Air Leak 5 5
Break 4 4
Material Separation 4 4
Gas/Air Leak 4 4
Crack 3 3
Material Fragmentation 2 2
Insufficient Information 2 2
Data Problem 1 1
Packaging Problem 1 1
Device Dislodged or Dislocated 1 1
Labelling, Instructions for Use or Training Problem 1 1
Contamination 1 1
Restricted Flow rate 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Sticking 1 1
Vibration 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Defective Device 1 1
Device Markings/Labelling Problem 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Misassembled 1 1
Occlusion Within Device 1 1
Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 45 45
No Clinical Signs, Symptoms or Conditions 12 12
No Known Impact Or Consequence To Patient 8 8
No Information 2 2
Low Oxygen Saturation 2 2
Cardiac Arrest 2 2
Death 2 2
Pneumonia 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sepsis 1 1
Anemia 1 1
Pleural Effusion 1 1
Congestive Heart Failure 1 1
Injury 1 1
Numbness 1 1
Respiratory Tract Infection 1 1
Choking 1 1
Sudden Cardiac Death 1 1
Bronchospasm 1 1
No Patient Involvement 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
No Code Available 1 1
Cough 1 1

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