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U.S. Department of Health and Human Services

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

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VYAIRE MEDICAL, INC STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number VMAX ENCORE 22 D
Device Problem Gas Leak
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.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
Type of DeviceCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Manufacturer (Section D)
VYAIRE MEDICAL, INC
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
VYAIRE MEDICAL, INC
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
kristin graf
22745 savi ranch parkway
yorba linda , CA 92887
MDR Report Key7529947
Report Number9615102-2018-00002
Device Sequence Number1
Product CodeBTY
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 22 D
Device Catalogue Number777405-103
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/21/2018 Patient Sequence Number: 1
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