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

Model Number 22D E

Device Problems Fumes or Vapors (2529); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.The vyaire technical support in conjunction with the customer determined the most likely cause of the issue was the vmax 22 solenoid board was burned out.The ts ordered replacement module under warranty and a return good authorization (rga) has been issued.At this time, vyaire has not received the suspected device for evaluation.

Event Description

The customer reported while using the calculator, predicted values, pulmonary function; the customer noted a burnt smell.The customer reported there was no patient involvement associated with the event.

Manufacturer Narrative

The vyaire failure analysis laboratory received the suspect component for investigation.The reported failure was isolated to burnt tracings caused by an internal short circuit of the solenoid tubing assembly.This issue will be internally investigated within vyaire.

• Brand Name: VMAX ENCORE
• Type of Device: CALCULATOR, PREDICTED 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: 9375957
• MDR Text Key: 189485558
• Report Number: 2021710-2019-11066
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K942211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

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
• Device Operator: Health Professional
• Device Model Number: 22D E
• Device Catalogue Number: 777405-103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1