MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE HYGROSCOPIC CONDENSER HUMIDIFIER/FILTER (HCHF); HEAT/MOISTURE EXCHANGER, SINGLE-USE

Model Number	AIRLIFE¿ HYGROSCOPIC CONDENSER HUMIDIFIER/FILTER (HCHF)
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be 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 airlife¿ hygroscopic condenser humidifier (hchf) causing elevated co2 levels, decreased tidal volumes, and increased work of breathing with ventilated patient.The customer confirmed there was no harm occurred to the patient.The staff caught the issue and prevented the harm.There was mild deterioration in blood gas values.
Additional Manufacturer Narrative
Result of investigation: according to the investigation, it was observed that all samples are acceptable.Therefore the defect reported by the customer cannot be confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE HYGROSCOPIC CONDENSER HUMIDIFIER/FILTER (HCHF)
• Common Device Name: HEAT/MOISTURE EXCHANGER, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10643499
• Report Number: 8030673-2020-00123
• Device Sequence Number: 571074
• Product Code: BYD
• UDI-Device Identifier: 10190752147218
• UDI-Public: (01)10190752147218(10)0004103291
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/10/2020

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: AIRLIFE¿ HYGROSCOPIC CONDENSER HUMIDIFIER/FILTER (HCHF)
• Device Catalogue Number: 5723EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1