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

Catalog Number AMAB3801

Device Problem Leak/Splash (1354)

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

Event Date 05/09/2018

Event Type  malfunction  

Event Description

Canisters leaking.

• Brand Name: AMSORB G-CAN
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): ARMSTRONG MEDICAL, LTD.; vc/fda consulting; 7549 spring lake dr. no. c-2; bethesda MD 20817
• MDR Report Key: 8424061
• MDR Text Key: 138908795
• Report Number: 8424061
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: AMAB3801
• Device Lot Number: 24071
• 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: 03/01/2019
• Date Report to Manufacturer: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1