Vyaire V-707960Recalls & reported problems
Jaeger Medical GmbH · Vyntus ONE · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250892905747), received between Nov 22, 2024 and Nov 22, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- Abrasion2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 10/24/2024 IT WAS REPORTED TO VYAIRE THAT WHEN THE PATIENT PULLED ON THE USS SENSOR TO READJUST THE POSITIONING OF THE ARM THE USS SENSOR FELL OUT OF HOUSING. THIS RESULTED IN THE USS SENSOR HITTING THE PATIENT'S FACE AND CAUSING A CUT ON THE LIP. IT WAS REQUIRED TO APPLY A PLASTER/TISSUE TO THE INJURED LIP TO STOP THE BLEEDING. THIS INCIDENT OCCURRED TWICE IN THE SAME HOSPITAL, BUT WITH A DIFFERENT PATIENT ON A DIFFERENT DEVICE AND WITH ANOTHER HEALTHCARE PROFESSIONAL. THE OTHER INCIDENT WILL BE REPORTED IN A SECOND REPORT WITH OUR REFERENCE NUMBER (B)(4).
Patient problems: Abrasion
MAUDE report 20755730 ↗MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024 IT WAS REPORTED TO VYAIRE THAT WHEN THE PATIENT PULLED ON THE USS SENSOR TO READJUST THE POSITIONING OF THE ARM THE USS SENSOR FELL OUT OF HOUSING. THIS RESULTED IN THE USS SENSOR HITTING THE PATIENT'S FACE AND CAUSING A CUT ON THE LIP. IT WAS REQUIRED TO APPLY A PLASTER/TISSUE TO THE INJURED LIP TO STOP THE BLEEDING. THIS INCIDENT OCCURRED TWICE IN THE SAME HOSPITAL, BUT WITH A DIFFERENT PATIENT ON A DIFFERENT DEVICE AND WITH ANOTHER HEALTHCARE PROFESSIONAL. THE OTHER INCIDENT WILL BE REPORTED IN A SECOND REPORT WITH OUR REFERENCE NUMBER COM (B)(4).
Patient problems: Abrasion
MAUDE report 20755703 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.