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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORATED ELITE PROBE; ELITE 3MHZ PROBE
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NATUS NEUROLOGY, INCORPORATED ELITE PROBE; ELITE 3MHZ PROBE Back to Search Results
Model Number X1L001
Medical Device Problem Code Device Sensing Problem (2917)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/16/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Based on risk assessment conducted may 25, 2017, it was determined that there is a risk of injury if the malfunction were to recur.There have been no reported injuries.Reference field corrective action number: 3010611950/06/09/2017/001-r.
 
Event or Problem Description
Excessive static noise observed in elite probe.
 
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Brand Name
ELITE PROBE
Common Device Name
ELITE 3MHZ PROBE
Manufacturer (Section D)
NATUS NEUROLOGY, INCORPORATED
3150 pleasant view road
middleton WI 53562
MDR Report Key6656761
Report Number3010611950-2017-00027
Device Sequence Number1150569
Product Code JAF
UDI-Device Identifier00382830028233
UDI-Public00382830028233
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K982635
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 05/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberX1L001
Device Catalogue NumberN300
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/16/2017
Initial Report FDA Received Date06/21/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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