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U.S. Department of Health and Human Services

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

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VYAIRE MEDICAL STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number PHYSICIAN CHOICE ENCORE TOWER
Device Problem Electrical Power Problem
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.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
Type of DeviceCALCULATOR, 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 Key8345688
Report Number2021710-2019-09890
Device Sequence Number1
Product CodeBTY
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
0 PatientS WERE Involved in the Event:
Date FDA Received02/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPHYSICIAN CHOICE ENCORE TOWER
Device Catalogue Number777543-102
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/22/2010
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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