MAUDE Adverse Event Report: VYAIRE MEDICAL, INC VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number VMAX ENCORE 229C

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At this time, vyaire has not received the suspect device/component for evaluation.If additional information becomes available, it will be submitted in a follow up report.

Event Description

A customer reported to vyaire medical that, when toggling the cart power supply switch to the vmax encore 229c pulmonary function testing system, a spark was observed, which the customer felt and described as equivalent to a discharge of static electricity when touching something in a dry environment.The customer did not seek medical treatment and did not suffer any effects due to the shock.The system was not in use on a patient when the problem occurred.The customer was advised by vyaire medical technical support not to use the system until an evaluation by a field service representative (fsr) could be performed.The customer reported that they continue to use the system with no reoccurrence of the reported problem.A service visit by a vyaire field service representative has been scheduled to evaluate the system.

Manufacturer Narrative

A field service representative (fsr) performed service and replaced the isolation transformer and made necessary adjustments.The fsr noted that the customer will return the suspect isolation transformer to vyaire for evaluation.Vyaire has not received the device for evaluation.

Manufacturer Narrative

The device was returned to vyaire and an investigation was performed by the failure analysis lab.The original complaint was duplicated and the device was found to have a failed on/off switch.The failure is considered an isolated incident and no corrective action is indicated at this time.

• Brand Name: VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
• Type of Device: CALCULATOR, 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 Key: 6858969
• MDR Text Key: 85804849
• Report Number: 2021710-2017-06610
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2017

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 229C
• Device Catalogue Number: 777410-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 09/16/2017; 11/27/2017
• Supplement Dates FDA Received: 10/13/2017; 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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): Other