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

Catalog Number AMAB3801

Device Problem Leak/Splash (1354)

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

Event Date 12/07/2017

Event Type  malfunction  

Event Description

Staff found a bad lot of disposable absorber canisters that were creating a 700-900 ml/min leak in bag mode.We removed all of the affected absorber canisters from service.No harm to patients or staff.

• Brand Name: AMSORB PLUS
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): ARMSTRONG MEDICAL LTD.; kelaveshi vc/fda consulting; 7549 spring lake dr. no. c-2; bethesda MD 20817
• MDR Report Key: 7240794
• MDR Text Key: 99022920
• Report Number: 7240794
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/01/2018

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
• Device Operator: No Information
• Device Catalogue Number: AMAB3801
• Device Lot Number: 24071F21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1