MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER THE CHIN STYLE, HIGH CONCENTRATION REBRE; CANNULA, NASAL, OXYGEN

Model Number	MASK OXYGEN REBR W/7 TBG NO VALVE 50/CS
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other - the customer did not send a picture or physical sample for investigation.We require the physical sample and/or pictures as evidence to perform a better investigation and determine the cause of the reported defect the device history record of the fg part number 001205 with lot number 0004091561 was reviewed and no issues were found during its manufacturing.Therefore, the reported defect was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device was not returned.
Event or Problem Description
It was reported to vyaire medical that that for the management of patients with oap, they logically used the airlife¿ adult oxygen mask vinyl, under the chin style, high concentration rebreather mask (no vavles) with 7 feet (2.1 m) crush resistant oxygen tubing with 100% fio2 (fraction of inspired oxygen).However, for some time now, they have been experiencing a problem with its implementation.Despite high oxygen flow, suitable placement on the face, the reservoir of these masks remains flat.No sufficient filling is possible.This mask is ineffective despite the fact that the air intakes on both sides of the masks are sealed.
Additional Manufacturer Narrative
Based on the investigation and since the customer sent pictures and no physical sample of the fg part number 001205 with lot number 0004091561 for the investigation, we cannot confirm the reported defect since in the pictures sent by the customer, we can appreciate that the oxygen bag does not inflate when it is connected to an oxygen flow.However, this is normal for part number 001205 because the oxygen bag only inflates when it is being used by the patient, and this model, unlike others, does not have gaskets.In addition, (b)(4).Was reviewed, and controls were implemented for this type of defect.Based on the above reported defect, it was not confirmed, and the root cause was not established.Additional information: the mask model was changed.Oxygenation has been adapted with another device.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER THE CHIN STYLE, HIGH CONCENTRATION REBRE
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18360454
• Report Number: 8030673-2023-00366
• Device Sequence Number: 15396392
• Product Code: CAT
• UDI-Device Identifier: 10190752116344
• UDI-Public: (01)10190752116344(10)0004091561
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: MASK OXYGEN REBR W/7 TBG NO VALVE 50/CS
• Device Catalogue Number: 001205
• Device Lot Number: 0004091561
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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