MAUDE Adverse Event Report: Westmed LLC CARDINAL HEALTH; HMEF Filter and Elbow With Gas Sampling Port

Model Number	CHAAX3000A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction

• Brand Name: CARDINAL HEALTH
• Common Device Name: HMEF Filter and Elbow With Gas Sampling Port
• Manufacturer (Section D): Westmed LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): Westmed LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 50510175
• Report Number: 2028807-2026-00020
• Device Sequence Number: 18522062
• Product Code: CAH
• UDI-Device Identifier: 10885380057731
• UDI-Public: (01)10885380057731(10)585414
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K922492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: CHAAX3000A
• Device Catalogue Number: CHAAX3000A
• Device Lot Number: 585414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown