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	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgical procedure, the patient's ctco2 levels had been rising so it was decided to change out the absorber canister.When the new canister was in the cradle and placed into the upright position, a large piece of plastic from the canister flew off.The canister became jammed in a non-functional position.The team was not able to ventilate the patient and there was no ambu-bag in the room.The team finally got the equipment unjammed and put the old canister in the machine.Fortunately, the patient's oxygen saturations never dropped.The failure was discussed by the or team and the broken absorber canister was saved.During the discussion of the event, another team member reported that they had heard of several similar incidents (at least two, possibly four) of absorber canisters breaking in the anesthesia machine.However, this is the only one that was documented in an event report.The manufacture's representative was notified and will be following up with anesthesia team member.

• 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: 13017630
• Report Number: 13017630
• Device Sequence Number: 4948617
• 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): 12/07/2021
• 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
• Operator of Device: Other
• Device Model Number: AMAB3801GE
• Device Catalogue Number: AMAB3801GE 2105489-003 AMSORB
• 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
• 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: Male
• Date Report Sent to FDA: 12/14/2021