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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED EMU40EXQ BREAKOUT BOX
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NATUS MEDICAL INCORPORATED EMU40EXQ BREAKOUT BOX Back to Search Results
Model Number 028066
Device Problems Melted (1385); Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
Initial report ref natus complaint # (b)(4).The customer reported heat damage with emu40exq breakout box.The customer returned the questionnaire and reported no injuries.They stated the issue has occurred over time since (b)(6) 2021, and that the attached plate on the breakout box appears melted.The customer provided a photo of the damaged breakout box.The affected product has been requested to be returned for further investigation.
 
Event Description
The customer reported overheating of their emu40exq breakout box devices.The device gets hot and the label peels off, or they have a burnt look to them.The attached plate on the breakout box appears melted.There were no injuries reported.
 
Manufacturer Narrative
Follow up report 001 ref natus complaint # (b)(4).Correction to section b1., g2., h1., section d4., unique identifier (udi) (b)(4).Acceptable risk associated with the complaint as per line 2.2 in doc-010378 xltek eeg psg risk analysis spreadsheet.No death or serious injury, considered a customer inconvenience.Tpi-1741 was created to address the issue.The affected product has been requested to be returned for further investigation.
 
Event Description
The customer reported overheating of their emu40exq breakout box devices.The device gets hot and the label peels off, or they have a burnt look to them.The attached plate on the breakout box appears melted.There were no injuries reported.
 
Manufacturer Narrative
Follow up report 002 ref natus complaint # (b)(4).The customer provided photos of the serial numbers and damage to the emu40ex.The service technican sent the questionnaire to the customer.The customer returned the questionnaire and reported no injuries.They stated the issue has occurred over time since feb-2021, and that the attached plate on the breakout box appears melted.3 requests were made for the return of the defective units.The service technican spoke with the customer about returning the defective units.The customer reported using a loose backpack most of the time.They also used the case provided by natus and reported they overheated, and that the clear plastic pouches on the front of the natus pouches turned brown and had a melted look.The customer stated that the units became hot or warm to the touch before they used their backpacks and provided photos.The clinical team representative provided documentation referring to previous case (b)(4) supporting the use of natus pouches.The senior product manager included the general warning and list for approved accessories.Incident may be caused by device malfunction, deterioration in characteristics and/or performance, customer misuse or inadequacy in labeling or instructions for use.Dhr review: sep-14-2020.Install date: (b)(6) 2021.Investigation result code: neuro sbu|user error.Closure rationale: complaint verified, expected behavior.Low safety risk of harm, individual complaint related to issue stated.No death or serious injury, considered a customer inconvenience.Complaint will be included in trending data for further review and investigation if needed.
 
Event Description
The customer reported overheating of their emu40exq breakout box devices.The device gets hot and the label peels off, or they have a burnt look to them.The attached plate on the breakout box appears melted.There were no injuries reported.
 
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Brand Name
EMU40EXQ BREAKOUT BOX
Type of Device
EMU40EXQ BREAKOUT BOX
Manufacturer (Section D)
NATUS MEDICAL INCORPORATED
dba excel-tech ltd.
2568 bristol circle
oakville, ontario L6H 5 S1
CA  L6H 5S1
Manufacturer (Section G)
NATUS MANUFACTURING LIMITED
ida business park
gort, galway H91PD 92
EI   H91PD92
Manufacturer Contact
emma mcmahon
dba excel-tech ltd.
2568 bristol circle
oakville, ontario L6H 5-S1
CA   L6H 5S1
MDR Report Key12238058
MDR Text Key263835908
Report Number9612330-2021-00019
Device Sequence Number1
Product Code GWQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number028066
Device Catalogue Number028066
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/31/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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