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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL VMAX ENCORE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

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VYAIRE MEDICAL VMAX ENCORE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number VMAX ENCORE 22
Device Problem Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Date 08/15/2018
Event Type  Malfunction  
Manufacturer Narrative

Vyaire file identification number (b)(4). The customer was requested to return the suspect device for investigation. At this time, the device has not been received by vyaire and an evaluation cannot be completed.

 
Event Description

A customer reported to vyaire that the vmax encore system module made a loud noise followed by an ambient temperature warning and a smell consistent with electronics overheating and/or burning. The customer reported that there was no patient involvement and no harm to the end user associated with the reported problem.

 
Manufacturer Narrative

The suspect device was returned to vyaire and evaluated. The reported problem of loud noise and ambient temperature warning message was duplicated, however, the reported problem of a smell consistent with electronics overheating and/or burning could not be duplicated and no evidence of burnt components was found upon inspection of the unit.

 
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Brand NameVMAX ENCORE
Type of DeviceCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Manufacturer (Section D)
VYAIRE MEDICAL
26125 north riverwoods blvd
mettawa IL 60045
Manufacturer (Section G)
VYAIRE MEDICAL INC.
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
mindy faber
26125 north riverwoods blvd
mettawa, IL 60045
8727570116
MDR Report Key7801157
MDR Text Key117832673
Report Number2021710-2018-09221
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK981366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 22
Device Catalogue Number777404-101
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/19/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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