ELITE XMD010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for ELITE XMD010 manufactured by Natus Neurology Incorporated.

Event Text Entries

[185003891] Patient information - no patient injury reported, device malfunction occurred. Date of event requested from the customer but information not yet provided. Relevant tests / laboratory data - this section is not applicable as no patient injury occurred. Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury occurred. Suspect products - not applicable. Serial # - this section is not applicable as the medical device does not have a serial number. If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. If explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. Reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient. Concomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device. For use by user facility / importer - not applicable as we are not a facility or importer of device. If nd, give protocol # - this section is not applicable as the medical device is not ind. Adverse event terms - this section is not applicable to medical devices. If remedial action initiated , check type - this section is not applicable as no remedial action was initiated. If action reported to fda under 21 usc 360i (f), list correction / removal reporting number - this section is not applicable as there was no action reported under 21usc 360i(f).
Patient Sequence No: 1, Text Type: N, H10


[185003892] Customer states that the fetal doppler does not pick up well, especially with larger ladies and the sound is muffled and static filled.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010611950-2020-00006
MDR Report Key9863140
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-20
Date of Report2020-03-20
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS MICHELLE GREANEY
Manufacturer StreetNATUS MANUFACTURING LTD IDA BUSINESS PARK
Manufacturer CityGORT, H91PD92
Manufacturer CountryEI
Manufacturer G1NATUS NEUROLOGY INCORPORATED
Manufacturer Street3150 PLEASANT VIEW ROAD MIDDLETON
Manufacturer CityWISCONSIN,
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameELITE
Generic NameELITE
Product CodeIYN
Date Received2020-03-20
Model NumberXMD010
Catalog NumberXMD010
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNATUS NEUROLOGY INCORPORATED
Manufacturer Address3150 PLEASANT VIEW ROAD MIDDLETON WISCONSI, US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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