MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH KIT, VYNTUS WALK; Oximeter

Model Number	VYNTUS WALK 6MWT TABLET
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained that the battery of the vyntus walk tablet is swollen.There was no patient involvement reported.
Additional Manufacturer Narrative
The affected device has not been returned and the investigation is based on the pictures provided by the customer.The provided pictures show that the battery of the device is swollen.Therefore the reported issue could be confirmed.The samsung tablet is a third party device with appropriate documentation and have the appropriate declaration of conformity on file and adhere to all applicable safety standards.The lithium-ion batteries used in tablets are known to have the potential to swell within the device.The defective tablet will be replaced.As soon as the remedial action is completed a follow up report will be submitted.The risk evaluation results in a risk acceptance level of an acceptable health risk.

• Brand Name: KIT, VYNTUS WALK
• Common Device Name: Oximeter
• 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: 21761616
• Report Number: 9615102-2025-00166
• Device Sequence Number: 12909299
• Product Code: DQA
• UDI-Device Identifier: 54250892904899
• UDI-Public: (01)54250892904899
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142959
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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 WALK 6MWT TABLET
• Device Catalogue Number: V-178501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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