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

Model Number AMAB4001

Device Problem Gas/Air Leak (2946)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

The anesthesia provider changed out the amsorb canister before the case began and noticed there was a leak somewhere in the circuit.The amsorb canister was switched again and the problem was resolved.

• Brand Name: ARMSTRONG AMSORB CANISTER
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): ARMSTRONG MEDICAL LTD.; 11403 empire ln; rockville MD 20852
• MDR Report Key: 15592689
• MDR Text Key: 301630448
• Report Number: 15592689
• Device Sequence Number: 1
• Product Code: CBL
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AMAB4001
• Device Catalogue Number: AMAB4001
• Device Lot Number: 221221F312
• 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: 09/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Male