MAUDE Adverse Event Report: WESTMED, INC. FILTER; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	REF 6221
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Our staff have reported an "oily substance" condensing on the inside of our heat and moisture exchangers/filters (hmefs) that are used inline with our ventilators.We have put them out of service until further investigation.

• Brand Name: FILTER
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): WESTMED, INC.; 5580 s nogales hwy; tucson AZ 85706
• MDR Report Key: 11574448
• Report Number: 11574448
• Device Sequence Number: 3621886
• Product Code: CAH
• UDI-Device Identifier: 00709078000959
• UDI-Public: (01)00709078000959
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2021
• Report Date (Section F): 03/09/2021

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: No Information
• Device Model Number: REF 6221
• Device Lot Number: 050520N02
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/09/2021