MAUDE Adverse Event Report: VYAIRE MEDICAL, INC STATIC AND DYNAMIC COMPLIANCE; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number VMAX ENCORE 22 D

Device Problem Gas/Air Leak (2946)

Patient Problems Fatigue (1849); Malaise (2359)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

Several attempts have been made to contact the customer for additional information and to evaluate the suspect device for the reported issue.At this time, the customer has not responded to any contact attempts and vyaire medical has not received the suspected device for evaluation.Upon completion of a final evaluation, a supplemental report will be submitted.

Event Description

Our business partner from (b)(6) reported while using static and dynamic compliance; the staff employees are reporting symptoms of malaise and fatigue.The respiratory laboratory of clinic golnik performed control measurement of carbon monoxide (dlco) and found the dlco measurement is above the limit values inside the laboratory.The customer reported using two dlco gases per vmax unit each month.The customer reported during the winter season, there are only two windows which are kept closed and no additional ventilation is provided.The customer reported staff employees are known smokers.In addition, one of the employees discovered aneurysm and breast cancer.

Manufacturer Narrative

Results of investigation: as a result, vyaire's global customer support in conjunction with the distributor in slovenia sent their field service engineer on site for evaluation.An investigation was performed and the reported event could not be duplicated.The engineer performed a vmax acceptance test procedure (atp) that is specifically focused on gas leaks and found no leaks present.The engineer also reported the calculation of gas usage was performed and the result was normal.The engineer reported that there are no other systems in this room with carbon monoxide (co) tanks.The conclusive root cause could not be identified; therefore a definitive root cause could not be determined and corrective or preventive action is not indicated at this time.This complaint will be included in on-going complaint trending analysis.Vyaire medical continues to track and trend any incident related to this issue.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 7529947
• MDR Text Key: 108778179
• Report Number: 9615102-2018-00002
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: VMAX ENCORE 22 D
• Device Catalogue Number: 777405-103
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other