• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VYAIRE MEDICAL VMAX ENCORE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVMAX ENCORE
Type of DeviceCALCULATOR, 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 Key9375957
MDR Text Key189485558
Report Number2021710-2019-11066
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK942211
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22D E
Device Catalogue Number777405-103
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/06/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/08/2019
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-