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

Model Number	PHYSICIAN CHOICE ENCORE TOWER
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The suspected device was received and a failure investigation was conducted.The reported issue was confirmed and a damaged (burnt) contact was found on the isolation transformer's switch.This issue will be internally investigated within vyaire.
Event or Problem Description
The customer initially reported the static and dynamic compliance vmax device was unable to power on.The customer in conjunction with the field service representative determined the most likely caused of event vmax cart.Customer reported there was no patient involvement with the event.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Common Device Name: CALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8345688
• Report Number: 2021710-2019-09890
• Device Sequence Number: 1915176
• Product Code: BTY
• UDI-Device Identifier: 10846446021394
• UDI-Public: (01)10846446021394
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K981366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PHYSICIAN CHOICE ENCORE TOWER
• Device Catalogue Number: 777543-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1