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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL VMAX ENCORE 22 CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

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VYAIRE MEDICAL VMAX ENCORE 22 CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number 22 E
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2019
Event Type  Malfunction  
Manufacturer Narrative

Vyaire file identification: (b)(4). Any additional information received from the customer will be included in a follow-up report. The customer reported the suspected component is available for analysis and was ordered for return. At this time, vyaire has not received the suspected component for evaluation.

 
Event Description

The customer reported during installation of a device, the vmax encore 22 e was not functioning. When the customer changed the oxygen (o2) cell, reconnected the vacuum pump, the board started to burn. When the customer installed the same o2 cell on a loaner unit afterwards, the o2 cell was not functional. The customer reported it is unclear if the device burning of the board had anything to do with the o2 cell device not being functional when used. The customer reported there is no patient involvement associated with the event.

 
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Brand NameVMAX ENCORE 22
Type of DeviceCALCULATOR, PREDICTED 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 Key9593820
MDR Text Key175172110
Report Number2021710-2020-11283
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK942211
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Device Catalogue Number777404-101
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/2017
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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