MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS¿ ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION - SIZE 5; ANAESTHESIA FACE MASK, SINGLE-USE

Model Number	MASK, ANES, FLEX, ADULT SIZE 5, TOP VLV
Medical Device Problem Codes	Deflation Problem (1149); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the 6850 - mask, anes, flex, adult size 5, top vlv wouldn't fill up with air and little pieces broke off into the chamber.The customer confirmed that there was no patient harm associated with the reported event.
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.

• Brand Name: VITAL SIGNS¿ ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION - SIZE 5
• Common Device Name: ANAESTHESIA FACE MASK, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): SHENZHEN VITAL SIGNS-KTL MEDICAL INSTRUMENT CO LTD; building 3, no.88 north jiaoyu; road, gaoqiao industrial park; shenzhen guangdong 51811 7; CH 518117
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 15958531
• Report Number: 8030673-2022-00284
• Device Sequence Number: 5525817
• Product Code: CAI
• UDI-Device Identifier: 10190752147461
• UDI-Public: (01)10190752147461(10)1121126
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2022

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, ANES, FLEX, ADULT SIZE 5, TOP VLV
• Device Catalogue Number: 6850
• Device Lot Number: 1121126
• 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: 11/14/2022
• Initial Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 64 YR
• Patient Sex: Unknown