VYNTUS BODY PC
Received Jul 3, 2024 · Event occurred Jan 16, 2024
Report 9615102-2024-00151 · MDR key 19663740
Device
Generic name
Plethysmograph, Volume
Manufacturer
Vyaire Medical GmbhModel number
VYNTUS BODY PCCatalog number
31797-001
Product problems
- Unable to Obtain Readings
- Unable to Obtain Readings
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE INFORMATION ABOUT THE INCIDENT IS NOT COMPREHENSIBLE. THE CUSTOMER WAS ASKED TO ASSIST WITH UNDERSTANDING THE INCIDENT BUT HAS NOT ANSWERED TO DATE. THE RISK WILL BE EVALUATED AS SOON AS FURTHER INFORMATION ARE AVAILABLE AND A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
VYAIRE WAS INFORMED ON THE 20-MAY-2024 BY THE FDA THAT THE CUSTOMER REPORTED THIS INCIDENT UNDER THE REFERENCE NUMBER (B)(4). THE CUSTOMER REPORTED THE FOLLOWING: "SOFTWARE MALFUNCTIONED ON OUR VYAIRE VYNTUS BODY BOX IN LAB AND COULD NOT GET SPIROMETRY TESTING SCREEN TO PULL UP. TEST IS STRICTLY TIMED, SO THREW OFF TESTING ACCURACY AND LED TO MEDICATION NEEDING TO BE ADMINISTERED AGAIN ONCE GLITCH WAS FIXED BEFORE WE COULD CONTINUE. SOFTWARE UPGRADE NEEDED AS SOON AS POSSIBLE. DIFFERENT PROBLEMS CONTINUE TO PRESENT THEMSELVES ON DIFFERENT PARTS OF TESTING ON A MORE AND MORE FREQUENT BASIS."
Additional Manufacturer Narrative
THE INFORMATION ABOUT THE INCIDENT IS NOT COMPREHENSIBLE. THE CUSTOMER WAS ASKED TO ASSIST WITH UNDERSTANDING THE INCIDENT BUT HAS NOT ANSWERED TO DATE. THE RISK WILL BE EVALUATED AS SOON AS FURTHER INFORMATION ARE AVAILABLE AND A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THIS REPORT WAS DUE ON 20-JUL-2024, BUT WAS SUBMITTED LATE DUE TO AN SOFTWARE ERROR. THIS WAS NOTICED AFTER RECEIVING THE DENIED ACKNOWLEDGEMENT AND THE DATE OF THIS REPORT WAS CHANGED TO THE 11-JUL-2024. VYAIRE WAS INFORMED ON THE 20-MAY-2024 BY THE FDA THAT THE CUSTOMER REPORTED THIS INCIDENT UNDER THE REFERENCE NUMBER (B)(4). THE CUSTOMER REPORTED THE FOLLOWING: "SOFTWARE MALFUNCTIONED ON OUR VYAIRE VYNTUS BODY BOX IN LAB, AND COULD NOT GET SPIROMETRY TESTING SCREEN TO PULL UP. TEST IS STRICTLY TIMED, SO THREW OFF TESTING ACCURACY AND LED TO MEDICATION NEEDING TO BE ADMINISTERED AGAIN ONCE GLITCH WAS FIXED BEFORE WE COULD CONTINUE. SOFTWARE UPGRADE NEEDED AS SOON AS POSSIBLE. DIFFERENT PROBLEMS CONTINUE TO PRESENT THEMSELVES ON DIFFERENT PARTS OF TESTING ON A MORE AND MORE FREQUENT BASIS."