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

Model Number	SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
• Common Device Name: RESUSCITATION DEVICES
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11807424
• Report Number: 8030673-2021-00169
• Device Sequence Number: 11641501
• Product Code: OEV
• UDI-Device Identifier: 10190752145443
• UDI-Public: (01)10190752145443(10)0004178443
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 0004178443
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1