MAUDE Adverse Event Report: ARMSTRONG MEDICAL LTD AMSORB® PLUS; ABSORBENT, CARBON-DIOXIDE

Model Number	AMAB3801GE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction

• Brand Name: AMSORB® PLUS
• Common Device Name: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): ARMSTRONG MEDICAL LTD; 11403 empire ln.; rockville MD 20852
• MDR Report Key: 24648166
• Report Number: 24648166
• Device Sequence Number: 15994593
• Product Code: CBL
• UDI-Device Identifier: 05060505643701
• UDI-Public: (01)05060505643701
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2026
• Report Date (Section F): 02/12/2026

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
• Device Model Number: AMAB3801GE
• Device Lot Number: 240425F41
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/12/2026