MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH PRODUCT VYNTUS ONE PFT

Model Number	VYNTUS ONE PFT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 30-oct-2024 vyaire was informed by a customer that the uss module became dislodged from the fpv block when patient accidently pulled it out during spirometry test.The module did not hit the floor but the uss cable disconnect which caused damage to the cable.No patient harm occurred and patient did not require any medical attention.
Additional Manufacturer Narrative
On 31-oct-2024 a field service technician was on-site to investigate the problem.It was revealed that the error message "device not detected" appears because the uss cable was bent due to the fall of the module.As a resolution, the cable was replaced and the system is functional.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.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.

• Brand Name: PRODUCT VYNTUS ONE PFT
• Common Device Name: VYNTUS ONE PFT
• 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: 20796880
• Report Number: 9615102-2024-00160
• Device Sequence Number: 7809214
• Product Code: BZC
• UDI-Device Identifier: 04250892904702
• UDI-Public: (01)04250892904702
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: FDA PREMARKE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Repair,Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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 PFT
• Device Catalogue Number: V-178602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/27/2024
• 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