GRASS ELECTRODES F-E5GH-30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-11-23 for GRASS ELECTRODES F-E5GH-30 manufactured by Natus Manufacturing Limited.

Event Text Entries

[60844549] Dhr for (b)(4) was obtained and reviewed. All manufacturing work steps have been completed and signed for as per route card. In process test form for grass electrodes was reviewed. All tests were completed and signed off. No failures recorded. Customer has been contacted to provide the rest of the required information. We are in the process of gathering additional information. A letter listing outstanding information has been sent to customer to obtain additional information in order to submit follow up report and/or explain why required information was not provided and steps taken to obtain such information. Device available for evaluation: awaiting customer response if the device will be returned.
Patient Sequence No: 1, Text Type: N, H10


[60844550] The first night of use, three patients have had major skin rashes and redness.
Patient Sequence No: 1, Text Type: D, B5


[73574214] Manufacturer narrative: four grass electrodes were returned for investigation. No visual defects noted on inspection. No issues with the production of this lot of electrodes. The devices were found to have met specifications prior to shipment. No manufacturing anomalies were identified that may have caused or contributed to the reported event. This is the first event reported for this lot number to date. Based upon the available information a definitive root cause cannot be determined. It is unknown whether patient factors or cleaning process may have contributed to the reported event. Customer has been contacted on numerous occasions to provide the required information. The feedback received in relation to the below information was marked as not applicable. Correction: operator of the device has been specified more from health professional to nurse based on the customer feedback. Initial reporter and occupation has been corrected to health professional and other health professional respectively. Corrected from the initial report 3005581270-2016-00006 to the below: (b)(6). Despite our best efforts contact details for the contact person for initial reporter (healthcare facility) could not be obtained from the distributor that originally reported adverse event that happened in the healthcare facility. Distributor advised they can be contacted in the case of additional information required. Below is the distributor details: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005581270-2016-00008
MDR Report Key6126499
Report SourceDISTRIBUTOR
Date Received2016-11-23
Date of Report2016-10-27
Date of Event2016-10-14
Date Mfgr Received2017-04-03
Device Manufacturer Date2014-10-01
Date Added to Maude2016-11-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MICHAEL GALVIN
Manufacturer StreetIDA BUSINESS PARK
Manufacturer CityGORT, CO. GALWAY H91PD92
Manufacturer CountryEI
Manufacturer PostalH91PD92
Manufacturer Phone3539164740
Manufacturer G1NATUS MANUFACTURING LIMITED
Manufacturer StreetIDA BUSINESS PARK
Manufacturer CityGORT, CO. GALWAY H91PD92
Manufacturer CountryEI
Manufacturer Postal CodeH91PD92
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGRASS ELECTRODES
Generic NameGRASS GENUINE CUP ELECTRODES
Product CodeGXY
Date Received2016-11-23
Returned To Mfg2017-01-09
Model NumberF-E5GH-30
Catalog NumberF-E5GH-30
Lot Number10218683
OperatorNURSE
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNATUS MANUFACTURING LIMITED
Manufacturer AddressIDA BUSINESS PARK GORT, CO. GALWAY H91PD92 EI H91PD92


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-11-23

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