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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL INC. SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM) CARDIOPULMONARY RESUSCITATION AID KIT

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VYAIRE MEDICAL INC. SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM) CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation. No root cause has been determined yet. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
The customer reported that the supernova nasal pap ventilation system (medium) experienced tear in the bag during setup. The first option was to switch the bag but the crna opted to put tape over the tear in the bag. The customer confirmed that there was no patient harm associated with the reported event.
 
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Brand NameSUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL INC.
26125 n. riverwoods blvd.
mettawa IL 60045
Manufacturer (Section G)
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
cerrada via de la produccion
no. 85, parque undustrial mex
mexicali, 21397
MX 21397
Manufacturer Contact
erika bonilla
510 technology dr
irvine, IL 92618
7149227837
MDR Report Key12366181
MDR Text Key268103341
Report Number8030673-2021-00185
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
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 Number0004103160
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 Received08/26/2021
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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