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U.S. Department of Health and Human Services

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

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VYAIRE MEDICAL, INC STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number PHYSICIANS CHOICE ENCORE
Device Problem Calibration Problem (2890)
Patient Problem No Information (3190)
Event Date 01/04/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). As the correction for this event, the vyaire medial field service engineer installed a replacement module during an onsite visit. Results of investigation: the suspected device was received and a failure investigation was performed. The reported issue was confirmed and a burnt analyzer board was found. Upon further investigation, the failure analysis technician found there was shorted to ground by the pneumatic control board assembly mounting hardware. Several attempts have been made to contact the customer for additional information. At this time, the customer has not responded to any contact attempts and vyaire medical is unable to confirm the customer's reported device issue.

 
Event Description

The customer initially reported the static and dynamic compliance vmax device was showing lower than expected residual volume values.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
Type of DeviceCALCULATOR, PREDICATED 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 Key7539370
MDR Text Key109105936
Report Number2021710-2018-07897
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK981366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 05/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPHYSICIANS CHOICE ENCORE
Device Catalogue Number777544-102
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/17/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/23/2011
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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