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

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/11/2016

Event Type  malfunction  

Event Description

Using new amsorb cannisters of anesthesia absorbant.Multiple providers have reported difficulty using the cannisters of absorbant in the drager apolloa anesthesia machine absorbant holder.Manufacturer response for disposable anesthesia absorbant cannister, amsorg (per site reporter): took info, will look into it.

• 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: 5837278
• MDR Text Key: 50882791
• Report Number: 5837278
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• 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: 07/13/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PT HAVING SURGERY