MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH PRODUCT VYNTUS ONE

Model Number	VYNTUS ONE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A previous capa investigation identified the following root cause of this event: misuse of the uss as a ¿handle¿ to change the support arm position instead of using the proper handle of the support arm.This misuse loosens the mechanical connection between the uss and the fpv so it becomes insufficient to hold the uss in place.As a result of the capa, the instructions for use were updated accordingly to ensure that future incidents are avoided.The affected sensor was not sent back for investigation.A picture of the uss revealed that the sensor looks worn, which could be the reason why the uss sensor could come off the arm even more easily.Nevertheless, as new incidents of this type were reported by customers a new capa was raised to prevent further occurrences.This incident is classified with a risk level of medium and is an acceptable patient risk.
Event or Problem Description
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).

• Brand Name: PRODUCT VYNTUS ONE
• Common Device Name: VYNTUS ONE
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 20755730
• Report Number: 3010838917-2024-00127
• Device Sequence Number: 9263595
• Product Code: BZC
• UDI-Device Identifier: 04250892905747
• UDI-Public: (01)04250892905747
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: VYNTUS ONE
• Device Catalogue Number: V-178601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown