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

Model Number AMAB3801GE

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Event 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
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): ARMSTRONG MEDICAL LTD; 7549 spring lake dr. no. c-2; bethesda MD 20817
• MDR Report Key: 13017632
• MDR Text Key: 282342488
• Report Number: 13017632
• Device Sequence Number: 1
• Product Code: CBL
• UDI-Device Identifier: 05060505643701
• UDI-Public: 05060505643701
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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
• Date Report Sent to FDA: 12/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Sex: Male