MAUDE Adverse Event Report: NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK) CONNEX BRAIN MONITOR BREAKOUT BOX; ELECTROENCEPHALOGRAPH

Model Number 012378

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

Following natus complaint procedure, natus has requested the device back for investigation and has not received it in house yet.No findings available at this moment.Replacement provided to the customer.Investigation will be initiated upon receiving the device.

Event Description

Connex/brainmonitor breakout box seems to get hot.

Manufacturer Narrative

Following natus complaint procedure, natus requested the device back for investigation.After the connex/brain monitor breakout box was returned for invetsigation, units were tested inside and outside pouches with no abnormal finding.Temperature never exceeds 28 c during inhouse testing.The device found to function as per the specification.

Event Description

Connex/brain monitor breakout box seems to get hot.

• Brand Name: CONNEX BRAIN MONITOR BREAKOUT BOX
• Type of Device: ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK); 2568 bristol circle; oakville, L6H 5 S1; CA L6H 5S1
• MDR Report Key: 8699206
• MDR Text Key: 148006655
• Report Number: 9612330-2019-00004
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 012378
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other