MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CANISTER GUARDIAN 2000CC; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651-220

Device Problem Complete Blockage (1094)

Patient Problem No Information (3190)

Event Date 07/06/2018

Event Type  malfunction  

Event Description

When the suction canister attached to the anesthesia machine is bumped, the suction valve becomes occluded blocking suction.This happened with 2 separate suction canisters today.

Event Description

When the suction canister attached to the anesthesia machine is bumped, the suction valve becomes occluded blocking suction.This happened with 2 separate suction canisters today.

• Brand Name: CANISTER GUARDIAN 2000CC
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 8024096
• MDR Text Key: 125661397
• Report Number: 8024096
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2018,08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 65651-220
• Device Catalogue Number: 65651-220
• Device Lot Number: J804-045
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2018
• Date Report to Manufacturer: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6935 DA