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

Model Number	VYNTUS ONE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However, the customer reported that they have been having significant problems with the flow-head staying attached despite continued efforts to ensure it is secure/tight.It is detaching from the equipment at least a couple of times a week which is impacting on testing and patient safety.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that a patient underwent routine lung function tests on the vyntus one as per usual protocol.However, when the patient took an inspiratory effort during the transfer factor test, the flow head detached and consequently causing one of his teeth to break/loosen.The patient's hand was also injured.
Additional Manufacturer Narrative
Result of investigation: it is assumed that the defect of the tooth is a combination of the age of the patient, since after requesting for additional information it turned out that the patient was pretty old, and the dropping out of the uss.In addition, an internal investigation was done.If the instructions of the ifu were followed a dropping of the uss is not possible during measurement.Based on that it is assumed that the instruction was not followed correctly by the health care provider.The case is closed with no patient risk identified which may cause a risk for serious injury of the patient.
Additional Manufacturer Narrative
Result of investigation:risk assessment was completed and no patient risk identified.Minor risk as no predominant change of health associated with the reported injury.The issue is addressed in capa 000000920.

• Brand Name: VYNTUS ONE
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL; leibnizstrasse 7; hoechberg, 97204 ; GM 97204
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97201 ; GM 97201
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12564993
• Report Number: 9615102-2021-00121
• Device Sequence Number: 872191
• Product Code: BZC
• UDI-Device Identifier: 04250892904719
• UDI-Public: (01)04250892904719
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2021

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: VYNTUS ONE
• Device Catalogue Number: V-178603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 03/03/2022; 04/07/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 03/04/2022; 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown