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TPLC
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show TPLC since
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Device
spirometer, therapeutic (incentive)
Product Code
BWF
Regulation Number
868.5690
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1. K203378
Pulsehaler
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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