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

Model Number	SUPERNOVA NASAL PAP VENTILATION SYSTEM(LARGE)
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not 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 elastic bag designed to manually assist breathing had multiple holes formed at the folded seams of the product.There was no patient harm reported.
Additional Manufacturer Narrative
Device evaluation: d9, g3, g6, h2, h3,h6 and h10.The device history record of the p/n ssl-20 was reviewed in order to detect any issues related to the defect reported by the customer during its manufacturing.The complete lot was manufactured, inspected, and released per our internal procedures, and no issues were found.The customer sent one ssl-20 for the investigation.The sample was visually inspected according to pqas sel-20 etal and it was observed that the bag part number 71-10005 had a hole.Therefore, the defect reported by the customer was confirmed.However, our process and areas related to this complaint were reviewed but no issues were found.The root cause was undetermined.Although the root cause was undetermined, we notified our supplier about the issue with the green bags.Part number 71-10005, whose corrective and preventive actions will be provided under scar mx-2021-047.

• Brand Name: SUPERNOVA NASAL PAP VENTILATION SYSTEM(LARGE)
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, ; MX
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13266426
• Report Number: 2050001-2022-00030
• Device Sequence Number: 4761191
• Product Code: OEV
• UDI-Device Identifier: 10190752145467
• UDI-Public: (01)10190752145467(10)0004155700
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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(LARGE)
• Device Catalogue Number: SSL-20
• Device Lot Number: 0004155700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown