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TPLC
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Device
calculator, pulmonary function data
Product Code
BZC
Regulation Number
868.1880
Device Class
2
Premarket Reviews
Manufacturer
Decision
VYAIRE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
1. K190853
Vyntus BODY
VYAIRE MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
1. K190853
Vyntus BODY
MDR Year
MDR Reports
MDR Events
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
Adverse Event Without Identified Device or Use Problem
3
3
Defective Device
2
2
Electrical Shorting
2
2
Gas/Air Leak
2
2
Insufficient Information
2
2
Computer Software Problem
2
2
Smoking
2
2
Use of Device Problem
1
1
Electrical /Electronic Property Problem
1
1
Gas Output Problem
1
1
Device Emits Odor
1
1
Output above Specifications
1
1
Overheating of Device
1
1
Product Quality Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Explosion
1
1
Non Reproducible Results
1
1
Intermittent Communication Failure
1
1
Material Integrity Problem
1
1
Contamination /Decontamination Problem
1
1
Temperature Problem
1
1
Component Incompatible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
18
18
No Patient Involvement
5
5
Dyspnea
2
2
No Consequences Or Impact To Patient
2
2
Discomfort
2
2
Sore Throat
1
1
Loss of consciousness
1
1
Tooth Fracture
1
1
Decreased Respiratory Rate
1
1
Electric Shock
1
1
Low Blood Pressure/ Hypotension
1
1
Laceration(s)
1
1
Dizziness
1
1
Convulsion/Seizure
1
1
Abrasion
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Vyaire Medical, Inc.
I
May-08-2024
-
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