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

Model Number 10406

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

Reference sr (b)(4).Resubmitting the mdr, the mdr was submitted to the fda on november 29, 2018 but the transfer failed.In compliance with 21cfr part 820.198- quality system regulations and natus quality management system, we initiated the investigation of the reported failure.Upon investigation, it was determined that no abnormal heating conditions were observed.The device was evaluated and confirmed to be working within specifications.No risk to patient or user.Customer was sent a replacement device for resolution.

Event Description

Emu40 breakout box overheated.

• Brand Name: EMU40
• Type of Device: ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): NATUS MEDICAL INC. DBA EXCEL-TECH LTD (XLTEK); 2568 bristol circle; 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
• MDR Report Key: 10201651
• MDR Text Key: 200614050
• Report Number: 9612330-2018-00020
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other