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

Model Number	5700 A-S
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Application Program Version or Upgrade Problem (2881)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a cesarean section, the cabinet drawers were electronically inaccessible and an attempt to use the manual override failed because the user was unaware that the key was required for access.The device was immediately power cycled and worked correctly prior to the procedure.No injury or adverse impact to the patient was reported.The instructions for use and training procedure were updated.

• 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 92128 ; 7604489500
• MDR Report Key: 19449512
• Report Number: 3027652921-2024-00001
• Device Sequence Number: 3240456
• Product Code: BRY
• UDI-Device Identifier: 00860011670902
• UDI-Public: 00860011670902
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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: 05/18/2022
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2021
• 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: Female