MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE ADULT OXYGEN MASK VINYL; CANNULA, NASAL, OXYGEN

Model Number	AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER-THE-CHIN STYLE, 3 IN 1 MASK WITH 7' (2.1
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined at this time, since the investigation is still ongoing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the 001362 airlife¿ adult oxygen mask vinyl, under-the-chin style, 3 in 1 mask with 7' (2.1 m) crush-resistant tubing and u/connect-it adapter has a hole near the top of the bag where it connects to the face mask.The bag not filling with oxygen nor was it able to provide adequate relief with desaturation.A new non-rebreather was given to the patient, and she was able to recover without harm.
Additional Manufacturer Narrative
The suspect device was returned for evaluation, however, the sample was not evaluated since they are contaminated.Therefore, the root cause was not determined and no corrective or preventive actions will be taken.

• Brand Name: AIRLIFE ADULT OXYGEN MASK VINYL
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12274253
• Report Number: 8030673-2021-00183
• Device Sequence Number: 20184183
• Product Code: CAT
• UDI-Device Identifier: 10190752116276
• UDI-Public: (01)10190752116276
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER-THE-CHIN STYLE, 3 IN 1 MASK WITH 7' (2.1
• Device Catalogue Number: 001362
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention