MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE HMEF 1000/S WITH FLEXIBLE TUBE AND DOUBLE SWIVEL ELBOW, DISPOSABLE; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	AIRLIFE¿ HMEF 1000/S WITH FLEXIBLE TUBE AND DOUBLE SWIVEL ELBOW, DISPOSABLE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
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.However, the customer stated that the device is available for evaluation.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 to vyaire medical that two airlife hmef 1000/s with flexible tube and double swivel elbow, disposable leaks on 2 anesthesia circuits (180ml).The issue occurred during patient-use and the defective filters were replaced.The customer also indicated that due to the issue, patient management was delayed.No patient harm was noted.
Additional Manufacturer Narrative
Result of investigation: according to the photo investigation, the leakage was from the 22mm double swivel elbow and adapter.The retain sample of lot 0207771 was tested.And failed the leak test.The root cause is determined to be presence of o-ring and improper operator error that worker did not fully inspect with proper rotation speed.

• Brand Name: AIRLIFE HMEF 1000/S WITH FLEXIBLE TUBE AND DOUBLE SWIVEL ELBOW, DISPOSABLE
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10713358
• Report Number: 3004050971-2020-00008
• Device Sequence Number: 17070973
• Product Code: CAH
• UDI-Device Identifier: 10190752139848
• UDI-Public: (01)10190752139848(10)0207771
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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¿ HMEF 1000/S WITH FLEXIBLE TUBE AND DOUBLE SWIVEL ELBOW, DISPOSABLE
• Device Catalogue Number: 557019500
• Device Lot Number: 0207771
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 04/18/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention