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

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.

• Brand Name: VMAX ENCORE
• Type of Device: CALCULATOR, 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 Key: 7801157
• MDR Text Key: 117832673
• Report Number: 2021710-2018-09221
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VMAX ENCORE 22
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2006
• 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