NATUS EDX ELECTROMYOGRAPH SYSTEM 982A0597

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 2016-08-24 for NATUS EDX ELECTROMYOGRAPH SYSTEM 982A0597 manufactured by Natus Neurology, Incorporated.

Event Text Entries

[52942649] This adverse event was registered internally as a complaint (reference (b)(4)) for further investigation by natus. Based on a service call initiated on july 20, 2016, the customer requested that a natus field service representative perform an onsite evaluation of the equipment but continued to use the equipment. The field service representative evaluation occurred on july 29, 2016 and found that the emg system base was not functioning properly. On that date, the customer informed the field service representative of this adverse event. The device history record for emg system serial number (b)(4) was reviewed. All the system components met the manufacturing specifications at the time of release. Product componentry was returned to natus for further evaluation and found that a transformer had failed within the base unit which resulted in the reduction of the electrical stimulation function of the system. Patient files supplied by the customer were evaluated by a trained clinician. A risk assessment performed by natus personnel concluded that input and output functions were inconsistent with expected results that trained users should recognize. Regarding the patient in question, following an initial request for information made on august 4, 2016, the customer reported on august 23, 2016 that no actual medical intervention was required.
Patient Sequence No: 1, Text Type: N, H10


[52942650] Customer reported that their emg system is not getting any motor responses and stimulation sensories are low. This may have resulted in a misdiagnosis for the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010611950-2016-00007
MDR Report Key5901478
Report SourceHEALTH PROFESSIONAL
Date Received2016-08-24
Date of Report2016-07-29
Date of Event2016-07-21
Date Mfgr Received2016-07-29
Device Manufacturer Date2016-02-26
Date Added to Maude2016-08-24
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 ContactMR. RANDALL MOOG
Manufacturer Street3150 PLEASANT VIEW ROAD
Manufacturer CityMIDDLETON WI 53562
Manufacturer CountryUS
Manufacturer Postal53562
Manufacturer Phone6088298802
Manufacturer G1NATUS NEUROLOGY INCORPORATED
Manufacturer Street3150 PLEASANT VIEW ROAD
Manufacturer CityMIDDLETON WI 53562
Manufacturer CountryUS
Manufacturer Postal Code53562
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNATUS EDX ELECTROMYOGRAPH SYSTEM
Generic NameELECTROMYOGRAPH SYSTEM
Product CodeIKN
Date Received2016-08-24
Returned To Mfg2016-08-03
Model Number982A0597
Catalog Number982A0597
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNATUS NEUROLOGY, INCORPORATED
Manufacturer Address3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-08-24

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