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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM) RESUSCITATION DEVICES

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VYAIRE MEDICAL SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM) RESUSCITATION DEVICES Back to Search Results
Model Number SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
Device Problem Misassembled (1398)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2021
Event Type  malfunction  
Manufacturer Narrative
The device history record (dhr) review did not show any deviations to manufacturer specifications. For functionality failure, it is imperative to receive a sample to duplicate the failure as described. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
It was reported to vyaire medical that the abs bag arm connector elbow of supernova nasal pap ventilation system was put on backwards not allowing it to connect to the anesthesia machine. The customer confirmed that there was no patient involvement associated with the reported event.
 
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Brand NameSUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
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 Key11807424
MDR Text Key250025693
Report Number8030673-2021-00169
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
Type of Report Initial
Report Date 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2021
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 Number0004178443
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 Received04/15/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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