MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNOVA NASAL PAP VENTILATION SYSTEM(LARGE) 50-R3439-07; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number	SUPERNOVA NASAL PAP VENTILATION SYSTEM(LARGE) 50-R3439-07
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the ssl-20-supernova nasal pap ventilation system(large) 50-r3439-07 was used during an upper endoscopy.The device was defective, had multiple holes at the end of the bag and the color faded.The device was kept away.According to the crna and anesthesiologist, the same issue happened before.There is no known patient impact.
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.

• Brand Name: SUPERNOVA NASAL PAP VENTILATION SYSTEM(LARGE) 50-R3439-07
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618
• MDR Report Key: 14750320
• Report Number: 2050001-2022-00032
• Device Sequence Number: 5623626
• Product Code: OEV
• UDI-Device Identifier: 10190752145467
• UDI-Public: (01)10190752145467(10)0004185169
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/07/2022

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) 50-R3439-07
• Device Catalogue Number: SSL-20
• Device Lot Number: 0004185169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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