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

Model Number	SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Result of investigation: pictures were sent by the customer for evaluation.A damage in the green bag.Also the device history record for the reported lot number was reviewed and no issues were found.Therefore the defect reported by the customer was not confirmed.

• Brand Name: SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12366181
• Report Number: 8030673-2021-00185
• Device Sequence Number: 17115590
• Product Code: OEV
• UDI-Device Identifier: 10190752145443
• UDI-Public: (01)10190752145443(10)0004103160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 0004103160
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1