MAUDE Adverse Event Report: VYAIRE MEDICAL INC. NON INVASIVE VENTILATION (NIV) NON- VENTED FULL FACE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	NON INVASIVE VENTILATION (NIV) NON- VENTED FULL FACE MASK WITHOUT ANTI- ASPHYXIA
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical was unable to verify the customer's reported issue.The sample device has been discarded and not available for analysis.Additionally, there was no provided photo.Since the lot number of the product involved in the incident could not be provided by the customer, the device history record could not be reviewed and no investigation can be performed and the defect could not be confirmed.Therefore, root cause of failure could not be determined.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 non invasive ventilation (niv) non- vented full face mask without anti- asphyxiation valve (small) connector detached from the main body of the masks, while connected to a patient.There was no harm reported.
Additional Manufacturer Narrative
Result of investigation:the investigation using the retained sample reveals that it is normal for the plastic connector to detach from the mask.The 2 parts are assembled without glue, so they can be separated when needed.However, with no feedback from the customer, sample, or photo, neither the reported failure nor root cause can be confirmed.No corrective/preventive actions have been indicated by the manufacturer at this time.

• Brand Name: NON INVASIVE VENTILATION (NIV) NON- VENTED FULL FACE MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12037333
• Report Number: 3003862188-2021-00001
• Device Sequence Number: 4130957
• Product Code: BZD
• UDI-Device Identifier: 10885403415722
• UDI-Public: (01)10885403415722
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NOT AVAILABL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: NON INVASIVE VENTILATION (NIV) NON- VENTED FULL FACE MASK WITHOUT ANTI- ASPHYXIA
• Device Catalogue Number: NIV041S
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1