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

Model Number SUPERNOVA NASAL PAP VENTILATION SYSTEM(LARGE)

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2021

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13266412
• MDR Text Key: 284507315
• Report Number: 2050001-2022-00031
• Device Sequence Number: 1
• Product Code: OEV
• UDI-Device Identifier: 10190752145467
• UDI-Public: (01)10190752145467(10)0004102002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPERNOVA NASAL PAP VENTILATION SYSTEM(LARGE)
• Device Catalogue Number: SSL-20
• Device Lot Number: 0004102002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1