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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNO2VA SATELLITE KIT MEDIUM CARDIOPULMONARY RESUSCITATION AID KIT

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VYAIRE MEDICAL SUPERNO2VA SATELLITE KIT MEDIUM CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number SUPERNO2VA SATELLITE KIT MEDIUM
Device Problem Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
At this time, vyaire has not received the suspect device/component for evaluation. Investigation is still ongoing. Therefore, no root cause could be determined yet. Any additional information received from the customer will be included in a follow-up report.
 
Event Description
The customer reported that the superno2va satellite kit experienced oxygen leak where the green o2 connector meets clear tubing during patient use. The customer confirmed no patient harm.
 
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Brand NameSUPERNO2VA SATELLITE KIT MEDIUM
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
Manufacturer (Section G)
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
cerrada v[?]a de la producci[?]n
85 parque undustrial mex iii
mexicali, 21397
MX 21397
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd.
mettawa, IL 60045
MDR Report Key9816982
MDR Text Key206393745
Report Number8030673-2020-00090
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020281
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 02/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSUPERNO2VA SATELLITE KIT MEDIUM
Device Catalogue NumberSSM-20
Device Lot Number0004106641
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 Received02/13/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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