MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED EMU40EX BASE UNIT

Model Number 006550

Device Problems Overheating of Device (1437); Excessive Heating (4030)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2020 reference sr#1-740234502.Additional information has been requested from the customer.

Event Description

Customer reported part over heated and was hot to touch.

Manufacturer Narrative

(b)(6) 2020.Reference (b)(4).The unit and affected components have been requested to be returned back to middleton for product investigation.

Event Description

Customer reported part over heated and was hot to touch.No patient injury.

Event Description

Customer reported part over heated and was hot to touch.

Manufacturer Narrative

21 january 2021 ref sr# (b)(4).The customer reported the defective unit is overheating and melted.1) no death or serious injury caused.2) no burning smell or evidence of burning on the device.3) the device was being used for patient care at the time of the event.4) the device did not have contact with another hot object which could have caused the emu40ex chassis to melt.Product examination and functional testing: investigation results/repair notes - study running for 72 hours this unit did not get hot during the study running.It felt little warm but this is normal.No fault found and no user/patient was injured.Device complies with (b)(4) standards and since the enclosure is ul-94 certified and the printed circuit bare board material is fr4 and qualified under ul 94.There is no risk of the device igniting, or causing harm to the user/patient.Per hazard id 6.3 of doc-010378 eeg/psg risk analysis the risk is low - 3.Investigation result code: neuro sbu|no issues noted.

• Brand Name: EMU40EX BASE UNIT
• Type of Device: EMU40EX BASE UNIT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd. (xltex); 2568 bristol circle; oakville, ontarios, l6h 5s1, ; CA
• MDR Report Key: 10756947
• MDR Text Key: 215312890
• Report Number: 9612330-2020-00012
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006550
• Device Catalogue Number: 006550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1