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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS NEUROLOGY INCOPORATED NICOLET EEG - MONITOR SYSTEM
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NATUS NEUROLOGY INCOPORATED NICOLET EEG - MONITOR SYSTEM Back to Search Results
Model Number 982A0479
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/05/2021
Event Type  Injury  
Manufacturer Narrative
Initial report ref natus complaint#(b)(4).Customer alleges that patient received electrode burns.Per customer's account of the event: "skin damage occurred at the contact area between the electrode cup and the skin." "after 8 hours of monitoring, when the electrode cup was removed, it was found that there was a 0.5*0.5 skin broken under the electrode cup, and the skin broken was flushed." end user was given information on how to treat to proceed with treating patient, including "using artificial skin to protect the wound after locality's cleaning and disinfection".It was confirmed the electrode (part 019-478500 cup electrodes, 10mm, 1.5m) is from a domestic manufacturer, product does not belong to natus.Customer used nuprep skin prep gel and failure was confirmed to be attributed to user error.New staff was not familiar with electrode application workflow and scrubbed too hard over baby skin's.Nurse has been trained to correct workflow errors.Asked supplies manager to notify technomed of product failure and manufacturer of nuprep gel to be notified of the complaint.No product will be returned for evaluation, failure linked to user error.Per (b)(4) complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.No complaint trends have been identified.Acceptable risk associated with the complaint as per line 5.22 doc-(b)(4) eeg risk analysis spreadsheet.No death or serious injury, considered a customer inconvenience.No device history review required as distributed product, belongs to techomed (ref part 019-478500 cup electrodes, 10mm, 1.5m).
 
Event Description
Eeg monitoring system to monitor the brain and understand brain development.After 8 hours of monitoring, when the electrode cup was removed, it was found that there was skin broken under the electrode cup, and the skin broken was flushed.No death or serious injury.Failure linked to user error.
 
Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Customer alleges that patient received electrode burns.Per customer's account of the event: "skin damage occurred at the contact area between the electrode cup and the skin." "after 8 hours of monitoring, when the electrode cup was removed, it was found that there was a 0.5*0.5 skin broken under the electrode cup, and the skin broken was flushed." end user was given information on how to treat to proceed with treating patient, including "using artificial skin to protect the wound after locality's cleaning and disinfection".It was confirmed the electrode (part 019-478500 cup electrodes, 10mm, 1.5m) is from a domestic manufacturer, product does not belong to natus.Customer used nuprep skin prep gel and failure was confirmed to be attributed to user error.New staff was not familiar with electrode application workflow and scrubbed too hard over baby skin's.Nurse has been trained to correct workflow errors.Asked supplies manager to notify technomed of product failure and manufacturer of nuprep gel to be notified of the complaint.No product will be returned for evaluation, failure linked to user error.There are no capa's related to this issue and this complaint does not identify a deficiency in the product design and therefore a capa is not required.Per qms-004442 complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.No complaint trends have been identified.Acceptable risk associated with the complaint as per line 5.22 doc-014038 eeg risk analysis spreadsheet.No death or serious injury, considered a customer inconvenience.No device history review required as distributed product, belongs to techomed (ref part 019-478500 cup electrodes, 10mm,1.5m).Failure confirmed: no.Closure rationale: no action necessary, not a product complaint.
 
Event Description
Eeg monitoring system to monitor the brain and understand brain development.After 8 hours of monitoring, when the electrode cup was removed, it was found that there was skin broken under the electrode cup, and the skin broken was flushed.No death or serious injury.Failure linked to user error.
 
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Brand Name
NICOLET EEG - MONITOR SYSTEM
Type of Device
NICOLET EEG - MONITOR SYSTEM
Manufacturer (Section D)
NATUS NEUROLOGY INCOPORATED
3150 pleasant view road
middleton, 53562 WI
MDR Report Key12092158
MDR Text Key259145443
Report Number3010611950-2021-00004
Device Sequence Number1
Product Code GWQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number982A0479
Device Catalogue Number982A0479
Was Device Available for Evaluation? No
Date Manufacturer Received06/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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