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

Catalog Number 2105489-003

Device Problems Crack (1135); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2019

Event Type  malfunction  

Event Description

Biomedical responded on service call up to determine reason for anesthesia circuit leak test failure.Inspection of the anesthesia machine noted a pronounced crack on the forward side of the disposable co2 absorber canister just below the front compensation tube.Biomedical noted that this was the second occurrence of cracking in this section of the canister in the last two weeks.Because of the location of the crack it was determined that this was not impact damage due to the location of the absorber as it was nested in the absorber/patient circuit assembly.This section of the absorber was protected by a condenser assembly that would have prevented any impact damage.Damaged absorber retrieved to have manufacturer analyze reason for cracking.Manufacturer response for disposable prefill absorber canister, amsorb plus g-can (per site reporter).Awaiting manufacturer response.

• Brand Name: AMSORB PLUS G-CAN
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): ARMSTRONG MEDICAL, LTD.; 575 knightsbridge pkwy; lincolnshire IL 60069
• MDR Report Key: 8349438
• MDR Text Key: 136501203
• Report Number: 8349438
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2105489-003
• Device Lot Number: 091018F21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1