MAUDE Adverse Event Report: INTELLIGUARD GROUP, LLC INTELLIGUARD; INTELLIGUARD ANESTHESIA STATION, MODEL 5700 A-S

Model Number	5700 A-S
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
00124664.
Event or Problem Description
It was reported that in between cases a third party organization tray was placed on top of a loose syringe in drawer one, which caused the tray to act as an elevated obstruction catching on the interior after closure, preventing normal function.The drawer opened enough to create a gap where a file folder was used to dislodge the syringe and the tray was allowed to settle back down, removing the obstruction and restoring normal function of the drawer.No patient involvement was reported.

• Brand Name: INTELLIGUARD
• Common Device Name: INTELLIGUARD ANESTHESIA STATION, MODEL 5700 A-S
• Manufacturer (Section D): INTELLIGUARD GROUP, LLC; 12220 world trade dr,; suite 210; san diego CA 92128
• Manufacturer (Section G): INTELLIGUARD; 12220 world trade dr.; suite 210; san diego 92128
• Manufacturer Contact: hylene valdez kevorkain ; 12220 world trade dr; suite 210; san diego, CA 92128 ; 7604489500
• MDR Report Key: 19742861
• Report Number: 3027652921-2024-00002
• Device Sequence Number: 3701315
• Product Code: BRY
• UDI-Device Identifier: 00860011670902
• UDI-Public: 00860011670902
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: 5700 A-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown