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

Model Number VYNTUS ONE

Device Problem Mechanical Problem (1384)

Patient Problem Tooth Fracture (2428)

Event Date 09/03/2021

Event Type  Injury  

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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 274527058
• Report Number: 9615102-2021-00121
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 04250892904719
• UDI-Public: (01)04250892904719
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: VYNTUS ONE
• Device Catalogue Number: V-178603
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 03/03/2022; 04/07/2022
• Supplement Dates FDA Received: 03/04/2022; 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening