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

Model Number PHYSICIAN CHOICE ENCORE TOWER

Device Problem Electrical Power Problem (2925)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2018

Event Type  malfunction  

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 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
• Type of Device: CALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8345688
• MDR Text Key: 136526756
• Report Number: 2021710-2019-09890
• Device Sequence Number: 1
• Product Code: BTY
• UDI-Device Identifier: 10846446021394
• UDI-Public: (01)10846446021394
• 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
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2010
• 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