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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
D R BURTON HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENCHANT TEK CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUNG TRAINERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1

MDR Year MDR Reports MDR Events
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 12 12
Gas/Air Leak 4 4
Material Separation 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Break 2 2
Material Fragmentation 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 1 1
Particulates 1 1
Labelling, Instructions for Use or Training Problem 1 1
Contamination 1 1
Crack 1 1
Fracture 1 1
Packaging Problem 1 1
Vibration 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 16 16
No Clinical Signs, Symptoms or Conditions 12 12
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cardiac Arrest 1 1
Death 1 1
Sepsis 1 1
Numbness 1 1
Respiratory Tract Infection 1 1
Low Oxygen Saturation 1 1
Bronchospasm 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To 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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