MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) TREX; FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Event Description

Patient felt that the a-eeg equipment may have been frequently but not constantly interfering with his pm-defibrillator device.The a-eeg batteries and electrodes were removed and patient stated the problem "seemed" to stop.There are no complaints when the a-eeg equipment was connected to him in the lab.There is no known harm to the patient.

• Brand Name: TREX
• Type of Device: FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK); 5955 pacific center blvd; san diego CA 92121
• MDR Report Key: 9601216
• MDR Text Key: 175414520
• Report Number: 9601216
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/31/2019,12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA