Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
calculator, pulmonary function data
Product Code
BZC
Regulation Number
868.1880
Device Class
2
Premarket Reviews
Manufacturer
Decision
CAREFUSION GERMANY 234 GMBH
SUBSTANTIALLY EQUIVALENT
1
COSMED S.R.L.
SUBSTANTIALLY EQUIVALENT
1
PULMONE ADVANCED MEDICAL DEVICES, LTD
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
4
4
2017
1
1
2018
1
1
2019
7
7
2020
3
3
2021
5
5
2022
9
9
2023
8
8
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
9
9
Fumes or Vapors
3
3
Device Stops Intermittently
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Defective Device
2
2
Smoking
2
2
Gas/Air Leak
2
2
Electrical Shorting
2
2
Insufficient Information
2
2
Computer Software Problem
2
2
Leak/Splash
1
1
Improper Device Output
1
1
Material Integrity Problem
1
1
Contamination /Decontamination Problem
1
1
Output above Specifications
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Use of Device Problem
1
1
Device Emits Odor
1
1
Product Quality Problem
1
1
Explosion
1
1
Component Incompatible
1
1
Overheating of Device
1
1
Gas Output Problem
1
1
Intermittent Communication Failure
1
1
Electrical /Electronic Property Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Temperature Problem
1
1
Non Reproducible Results
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
18
18
No Patient Involvement
7
7
No Consequences Or Impact To Patient
3
3
No Known Impact Or Consequence To Patient
2
2
Discomfort
2
2
Dyspnea
2
2
Electric Shock
1
1
Dizziness
1
1
Abrasion
1
1
Tooth Fracture
1
1
Laceration(s)
1
1
Convulsion/Seizure
1
1
Headache
1
1
Sore Throat
1
1
Loss of consciousness
1
1
Low Blood Pressure/ Hypotension
1
1
Decreased Respiratory Rate
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Innovision A/S
II
Sep-08-2016
2
Vyaire Medical, Inc.
I
May-08-2024
-
-