MAUDE Adverse Event Report: NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK) EMU40; ELECTROENCEPHALOGRAPH

Model Number EMU40

Device Problem Overheating of Device (1437)

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

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

The device arrived on (b)(6) 2016.Natus will conduct an investigation and report to fda with a follow up report.

Event Description

A health care facility technician was having difficulties with 'breakout box disconnects' and was trying to resume the ltm recording, which had been going on for about a week.The technician reported that it was "hot to the touch" for at least 30 minutes.It was still hot after 15 minutes.No injury.

Manufacturer Narrative

The reported device has been returned, and upon investigation, natus could not reproduce the overheating issue.The device did not exhibit any sign of burn, and it performed to specification without any issue.

Event Description

A health care facility technician was having difficulties with 'breakout box disconnects' and was trying to resume the ltm recording, which had been going on for about a week.The technician reported that it was "hot to the touch" for at least 30 minutes.It was still hot after 15 minutes.No injury.

• Brand Name: EMU40
• Type of Device: ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK); 2568 bristol circle; oakville, oakville ontario L6H 5 S1; CA L6H 5S1
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED DBA EXCEL-TECH (XLTEK); 2568 bristol circle; oakville, ontario L6H5S 1; CA L6H5S1
• Manufacturer Contact: sanjay mehta ; 2568 bristol circle; oakville, ontario L6H5S-1 ; CA L6H5S1 ; 2875055
• MDR Report Key: 5871988
• MDR Text Key: 52964009
• Report Number: 9612330-2016-00005
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EMU40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1