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U.S. Department of Health and Human Services

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

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VYAIRE MEDICAL, INC STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Catalog Number 777400-102
Device Problem Failure to Power Up (1476)
Patient Problem No Patient Involvement (2645)
Event Date 07/17/2017
Event Type  Malfunction  
Manufacturer Narrative

Vyaire complaint #: (b)(4). Results of investigation: the vyaire factory service (fs) technician received the suspected device and performed a failure investigation. The reported issue was confirmed. The device would not power on. Also, a burnt analyzer board and solenoid cable were found during the investigation. It is unknown what the root cause of the failure is.

 
Event Description

The customer reported that the vmax module absolutely failed to power on. There was no patient involvement at the time of the reported issue.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
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 Key6994319
MDR Text Key91201666
Report Number2021710-2017-06905
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeTH
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
Report Date 11/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/01/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number777400-102
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/10/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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