MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT CANISTER 1200CC GUARDIAN; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65651-212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Based on the limited information provided by the end user facility and without a lot number or physical samples to conduct necessary laboratory testing, the assignable cause could not be confirmed.If a sample is provided at a later date, the case will be reopened, and investigation updated accordingly.The last six months of calibration certification for the lid testing equipment and the dhrs (device history records) from august 2023 to february 2024 for the guardian canister products were reviewed with no identifiable deficiencies noted.There are two failure modes which could possibly cause loss of suction for a guardian canister with mechanical shutoff: (1) using it on its side and (2) bumping the unit causing the float to rise-up and shut off the vacuum.There are instructions that warn against improper use and for re-starting the guardian product if it pre-maturely shuts off.We will continue to monitor based on our current process and procedures.
Event or Problem Description
Customer called with questions about medivac guardian 1200cc canister.They had an incident with use where suction was lost while using, and a patient died.

• Brand Name: CANISTER 1200CC GUARDIAN
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer (Section G): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 18908673
• Report Number: 1423537-2024-00012
• Device Sequence Number: 6130749
• Product Code: GCX
• UDI-Device Identifier: 50630140152533
• UDI-Public: 50630140152533
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 65651-212
• Device Catalogue Number: 65651-212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown