MAUDE Adverse Event Report: (S)SUB MASK/SIZE 5/ADULT; ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE

Model Number	(S)SUB MASK/SIZE 5/ADULT
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
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 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 customer reported that the limb-o¿ single limb anesthesia breathing circuit experienced very deflated which makes it difficult to get a quality seal to mask ventilate patients.As an intervention, anesthesia technicians manually inflate the mask via the tail valve using a syringe.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Result of investigation: only photos received for evaluation.Visual inspection can be seen mask is deflated.Therefore, the root cause is determined to be manufacturing process - supplier manufacturing process.
Event or Problem Description
The customer reported that the (s)sub mask/size 5/adult experienced very deflated which makes it difficult to get a quality seal to mask ventilate patients.As an intervention, anesthesia technicians manually inflate the mask via the tail valve using a syringe.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Result of investigation: sample was received for investigation.A visual inspection was performed and found the mask deflated.Therefore, reported defect was confirmed.

• Brand Name: (S)SUB MASK/SIZE 5/ADULT
• Common Device Name: ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE
• MDR Report Key: 11815474
• Report Number: 8030673-2021-00166
• Device Sequence Number: 17085608
• Product Code: CAI
• UDI-Device Identifier: 10190752121867
• UDI-Public: (01)10190752121867(10)1223361
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2021

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: (S)SUB MASK/SIZE 5/ADULT
• Device Catalogue Number: AFN580AC
• Device Lot Number: 1223361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/19/2021; 06/22/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/10/2021; 07/14/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention