MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYNTUS ONE PC; CALCULATOR, PULMONARY FUNCTION DATA

Model Number	VYNTUS ONE PC
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the keyboard of the vyntus one laptop from dell is puffed out, which possibly could be the result of a swollen battery.There was no patient involvement.
Additional Manufacturer Narrative
As the device was not returned and the complaint could not be confirmed, a specific root-cause could not be determined.The customer received a replacement laptop.The dell laptop is a third party device which is not further investigated by vyaire.Dell has the appropriate declaration of conformity and adheres to all applicable safety standards.The usage of laptops which fulfil applicable safety standards is state of the art.The customer will be informed that a swollen battery poses a safety risk to users and patients.Therefore the laptop should be returned to vyaire or if that is not possible, scrapped in accordance with hazardous materials disposal.The risk evaluation of this complaint results in a risk acceptance level of a medium acceptable health risk.

• Brand Name: VYNTUS ONE PC
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• 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: 20243843
• Report Number: 9615102-2024-00155
• Device Sequence Number: 17967162
• Product Code: BZC
• UDI-Device Identifier: 04250892904719
• UDI-Public: (01)04250892904719
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 09/18/2024

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 PC
• Device Catalogue Number: 31776-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/18/2024
• 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