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

Model Number (S)SUB MASK/SIZE 5/ADULT

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  Injury  

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 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.

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 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.

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
• Type of Device: ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE
• MDR Report Key: 11815474
• MDR Text Key: 250315337
• Report Number: 8030673-2021-00166
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752121867
• UDI-Public: (01)10190752121867(10)1223361
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention