MAUDE Adverse Event Report: VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X -LARGE AD
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
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 product is available to be returned for investigation.Pictures are also attached.The customer reported to vyaire medical that the 6861- vital signs® extra large face mask with adjustable air cushion size 6x -large adult face mask, deflated while connected to a patient.The customer confirmed that there was no harm and there was no intervention needed.
Additional Manufacturer Narrative
Device evaluation: one opened sample part number r6860k was received for the investigation.Based on the investigation and per the physical sample and pictures provided by the customer, we could observe that the blue valve is loose inside the cushion, so the defect was confirmed.We determined that the material could be related since the part number r6860k is not manufactured in vyaire mexicali and we do not manipulate the blue valve.In addition, the pfmea 76a refers to the pfmea 83a for raw material, and we have the controls for this kind of issue.As a corrective and preventive action, scar mx-2021-030 was initiated for the external supplier.Also, personnel was notified about the complaint.

• Brand Name: VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• MDR Report Key: 12081210
• Report Number: 8030673-2021-00177
• Device Sequence Number: 16981462
• Product Code: CAI
• UDI-Device Identifier: 10190752147379
• UDI-Public: (01)10190752147379
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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: VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X -LARGE AD
• Device Catalogue Number: 6861
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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