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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 VMAX ENCORE 229E
Device Problem Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Results of investigation: the device was evaluated by a vyaire medical engineer on-site. The engineer was able to duplicate the problem. The engineer identified the issue to the customer's process on using "patient demographic" function instead of the recommended work flow by using "find a patient" function. The issue was resolved by advising the customer on properly importing data from the microloop software to vmax software by using the "find a patient" function. A change to the software will be included in the next version to prevent the customer from using this process incorrectly.

 
Event Description

The customer reported while uploading data to the vmax software version 28-5b, data was populated erroneously to a patient's test results. The issue occurred during patient use but there was no report of patient impact associated with this event.

 
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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 Key6892686
MDR Text Key87864200
Report Number2021710-2017-06692
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 229E
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 Received08/30/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2006
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: 09/25/2017 Patient Sequence Number: 1
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