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

Model Number	VYNTUS BODY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during installation of the vyntus bodybox door the door fell on the service technician.There was no physical harm to the service technician besides fragments of glass entering his hair and footwear.It was confirmed that the technician was not wearing the necessary safety clothing (e.G.Safety gloves, safety goggles) for the installation of a vyntus bodybox.
Additional Manufacturer Narrative
The shattered vyntus bodybox door was not returned for an investigation and also no pictures were provided.The service technician investigated what was left from the door and discovered that the bottom hinge on the body box had a cracked black insert sleeve which might contributed the safety glass to break.The risk of a bodybox door shattering during installation is covered in the risk management file.To reduce the risk safety goggles and safety gloves must be worn during installation to minimize the severity of harm.As no safety clothing was worn in this case, there was no risk reduction and there is a potential risk of impaired visual function, which is why this incident was classified as a reportable incident.The supplier was informed about the incident and confirmed that there were no anomalies during production.In addition, there are no known faults regarding broken bushings in the door hinges and no cracks in the door glass have been reported during production.It is assumed that the fault on the hinge occurred during transportation and caused the safety glass to crack during installation.As a resolution a new vyntus bodybox door was delivered to the customer and installed on (b)(6) 2025.The risk evaluation results in a risk acceptance level of a medium acceptable health risk.

• Brand Name: VYNTUS BODY
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): ZOLLNER ELEKTRONIK AG; wiesenweg 1,; zandt 93499 ; GM 93499
• Manufacturer Contact: jared cardon ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 21897513
• Report Number: 9615102-2025-00171
• Device Sequence Number: 15478273
• Product Code: BZC
• UDI-Device Identifier: 04250892904689
• UDI-Public: (01)04250892904689
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190853
• 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): 04/17/2025

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 BODY
• Device Catalogue Number: V-178500-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/24/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown