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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYNTUS ONE; CALCULATOR, PULMONARY FUNCTION DATA
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VYAIRE MEDICAL GMBH VYNTUS ONE; CALCULATOR, PULMONARY FUNCTION DATA Back to Search Results
Model Number V-178600-13
Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2022
Event Type  malfunction  
Event Description
During inspiratory maneuvers for dlco (diffusion capacity of the lung for carbon monoxide) measurement during pulmonary function testing (pft), the machine was excessively chattering.A second device also produced the same issues.After further evaluation of the pft data, it was found that the results were inaccurate and unreliable for 28 different patients.Manufacturer response for pulmonary function testing machine, vyntus one (per site reporter) numerous on-site service calls were made by vyaire service technicians to the facility to perform service on both devices to try to correct the ongoing issues.
 
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Brand Name
VYNTUS ONE
Type of Device
CALCULATOR, PULMONARY FUNCTION DATA
Manufacturer (Section D)
VYAIRE MEDICAL GMBH
26125 n riverwoods blvd
mettawa IL 60045
MDR Report Key15833586
MDR Text Key304003018
Report Number15833586
Device Sequence Number1
Product Code BZC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberV-178600-13
Device Catalogue NumberV-178600-13
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/10/2022
Device Age0 YR
Event Location Other
Date Report to Manufacturer11/21/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/21/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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