MAUDE Adverse Event Report: JAEGER MEDICAL GMBH VYNTUS BODY APS; WHOLE-BODY PLETHYSMOGRAPHY

Model Number	V-378510
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Loss of consciousness (2418); Cough (4457)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available to date, an internal investigation was initiated to assess the reported patient reactions and the concerns regarding nebulizer output performance during bronchial provocation testing.As a first step, additional information was requested from the customer.This included the detailed bronchial provocation protocols used during the affected tests as well as anonymized patient related data, in order to better understand the test conditions and administered doses.A review of the reported measurements indicated variability in nebulizer output values when different filling volumes and test setups were used.As the influence of filling volume on nebulizer output could not be excluded based on the available data, further clarification was considered necessary.To objectively assess this potential influencing factor, it was decided to involve an external accredited laboratory.The purpose of this testing will be to evaluate whether the volume of solution in the nebulizer container has an impact on the measured output and to what extent this may affect dose delivery during use.The investigation remains ongoing and will be updated once the requested protocols and the external laboratory results are available.Results of the assessment: the malfunction resulted in a medium risk for a patient, user or 3rd-party.
Event or Problem Description
It was reported that during recent histamine provocation testing using the vyntus body aps system, two patients experienced discomfort during bronchial provocation testing with histamine.The histamine concentration used was 16 mg/ml and the provocation protocol consisted of four steps of 0.015, 0.045, 0.18 and 0.72.One patient experienced hot flushes and dizziness and developed bronchoconstriction with a significant reduction in fev, resulting in a positive bronchial challenge response.Another patient did not show bronchoconstriction but fainted in the test booth for a few seconds.No further symptoms beyond discomfort, dizziness and fainting were reported.In addition, concerns were raised regarding the nebulizer output during use of the aps system.Measurements performed on site by the customer using saline solution and a precision scale indicated higher nebulizer output values than expected based on available technical information.This led to uncertainty regarding the amount of substance administered to patients during bronchial provocation testing.Furthermore, concerns were expressed about the reliability of nebulizer performance when different filling volumes are used.It was noted that the nebulizer cup is graduated up to higher volumes, which may give the impression that accurate and safe administration is ensured across the full range, potentially leading to use outside the intended operating conditions.

• Brand Name: VYNTUS BODY APS
• Common Device Name: WHOLE-BODY PLETHYSMOGRAPHY
• Manufacturer (Section D): JAEGER MEDICAL GMBH; leibnizstrasse 7; hoechberg, bavaria 97204 ; GM 97204
• Manufacturer Contact: jared cardon ; leibnizstrasse 7; hoechberg, bavaria 97204 ; GM 97204
• MDR Report Key: 24001206
• Report Number: 1000271197-0001-02026
• Device Sequence Number: 10184858
• Product Code: BZC
• UDI-Device Identifier: 04250892908304
• UDI-Public: (01)04250892908304
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Repair,Replace
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: V-378510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/08/2026
• 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
• Outcome Attributed to Adverse Event: Disability; Other
• Patient Sex: Unknown