• 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, INC VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS 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, INC VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
Type of DeviceCALCULATOR, 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 Key6858969
MDR Text Key85804849
Report Number2021710-2017-06610
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK942211
Number of Events Reported1
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
Date FDA Received09/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 229C
Device Catalogue Number777410-101
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/12/2017 Patient Sequence Number: 1
-
-