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	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Another failure with the soda lime canister fracturing.Team was unable to ventilate the patient on the gas machine and had to emergently ambu the patient until a new soda lime canister was found.Team complaining numerous issues with cracked canisters.Unfortunately, the fractured canister was not saved nor were photographs taken.The patient did not have an adverse outcome because of this event.

• Brand Name: AMSORB PLUS
• Common Device Name: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): ARMSTRONG MEDICAL LTD; 7549 spring lake dr. no. c-2; bethesda MD 20817
• MDR Report Key: 13017632
• Report Number: 13017632
• Device Sequence Number: 4948618
• Product Code: CBL
• UDI-Device Identifier: 05060505643701
• UDI-Public: 05060505643701
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/14/2021
• Report Date (Section F): 12/14/2021

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
• Device Model Number: AMAB3801GE
• Device Catalogue Number: 2105489-003
• Device Lot Number: 180321F311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2021
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/14/2021