MAUDE Adverse Event Report: ALPHA OMEGA ENGINEERING LTD. NEURONAV; ELECTRODE, DEPTH

Device Problems Failure to Power Up (1476); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  malfunction  

Event Description

Equipment malfunction.Did not start up.

• Brand Name: NEURONAV
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): ALPHA OMEGA ENGINEERING LTD.; 5755 north point pkwy; suite 229; alpharetta GA 30022
• MDR Report Key: 17097416
• MDR Text Key: 316860868
• Report Number: 17097416
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2023,10/25/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 06/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Female