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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNOVA RESUSCITATION DEVICES

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VYAIRE MEDICAL SUPERNOVA RESUSCITATION DEVICES Back to Search Results
Model Number SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
Vyaire medical was able to confirmed the reported issue, and traced that the root cause was related to the manufacturing process supplier manufacturing process. As capa, all the personnel involved were retrained on spm snl-20, and a quality notification was created, and sent to our external supplier.
 
Event Description
It was reported to vyaire medical that during clinical settings, the ssm-20 supernova nasal pap ventilation system (medium) was not inflating, and holes were detected. As a resolution, the bag was replaced, and there was no patient harm reported.
 
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Brand NameSUPERNOVA
Type of DeviceRESUSCITATION DEVICES
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
no. 85, parque undustrial mex
mexicali, 21397
MX 21397
Manufacturer Contact
peter sparacio
26125 n. riverwoods blvd.
mettawa, IL 60045
8333273284
MDR Report Key10820278
MDR Text Key216213771
Report Number8030673-2020-00126
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 10/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
Device Catalogue NumberSSM-20
Device Lot Number0004094596
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

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