MAUDE Adverse Event Report: JAEGER MEDICAL GMBH PRODUCT VYNTUS ONE; CALCULATOR, PULMONARY FUNCTION DATA

Model Number	PRODUCT VYNTUS ONE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Headache (1880)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was submitted later than required because the incident, initially reported by the customer to a jaeger employee on 21-mar-2025, was not escalated to the appropriate department until 16-may-2025.The device was not returned for an investigation.A prior capa investigation identified the root cause of this type of event as improper handling of the ultrasonic sensor (uss).Specifically, the uss was used as a handle to reposition the support arm, rather than using the designated handle.This misuse can loosen the mechanical connection between the uss and the fpv, compromising the sensor¿s ability to remain in place.As a corrective action, the instructions for use (ifu) were updated to emphasize proper handling procedures.The customer was informed regarding the proper handling of the device in accordance with the ifu.The risk evaluation results an acceptable health risk.
Event or Problem Description
It was reported that after the patient was seated for a lung function test, the clinician lowered the arm holding the ultrasonic flow sensor into position.During this process, the sensor head became dislodged from the arm and struck the patient on the forehead.The patient was placed under observation for 24 hours and, aside from experiencing mild dermatologic irritation and a transient headache the following day, sustained no harm.There were no bruising or cuts observed the following day.

• Brand Name: PRODUCT VYNTUS ONE
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): JAEGER MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer Contact: jared cardon ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 22094210
• Report Number: 9615102-2025-00172
• Device Sequence Number: 20564349
• Product Code: BZC
• UDI-Device Identifier: 04250892904696
• UDI-Public: (01)04250892904696
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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: PRODUCT VYNTUS ONE
• Device Catalogue Number: V-178601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/28/2025
• 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 Age: 75 YR
• Patient Sex: Female