MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNOVA; RESUSCITATION DEVICES

Model Number	SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: SUPERNOVA
• Common Device Name: RESUSCITATION DEVICES
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10820278
• Report Number: 8030673-2020-00126
• Device Sequence Number: 4123117
• Product Code: OEV
• UDI-Device Identifier: 10190752145443
• UDI-Public: (01)10190752145443(11)20190519(10)0004094596
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K020281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
• Device Catalogue Number: SSM-20
• Device Lot Number: 0004094596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1