NOMAD PRO 2 0.850.0021

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-12 for NOMAD PRO 2 0.850.0021 manufactured by Aribex.

Event Text Entries

[120105426] The unit was returned and an engineering evaluation completed. Visual inspection shows signs of electrolyte leakage on the tube head plastic enclosure and a thermal event in lower battery pack. It is not possible to determine the exact sequence of events that led to the thermal event. However, there is evidence that a short occured in the lower battery pack between the cells and printed circuit board. There was a blackening on the top of the lower battery pack and its printed circuit board (pcb). Cells 2 and 3 appear to have been involved in the thermal event, likely by supplying energy into a fault in the board. Additionally, there was a slight melting of the handset plastic enclosure. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10


[120105427] It was reported that the unit was leaking a substance. The device had not been dropped. There was no report of patient or user injury, no patient or user involvement, and no impact to patient care.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1017522-2018-00026
MDR Report Key7870400
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-09-12
Date of Report2018-09-12
Date of Event2018-08-14
Date Mfgr Received2018-08-14
Device Manufacturer Date2014-02-12
Date Added to Maude2018-09-12
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 ContactMS. ERIKA MARTIN
Manufacturer Street11727 FRUEHAUF DRIVE
Manufacturer CityCHARLOTTE NC 28273
Manufacturer CountryUS
Manufacturer Postal28273
Manufacturer G1ARIBEX
Manufacturer Street11727 FRUEHAUF DRIVE
Manufacturer CityCHARLOTTE NC 28273
Manufacturer CountryUS
Manufacturer Postal Code28273
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOMAD PRO 2
Generic NameEXTRAORAL SOURCE X-RAY SYSTEM
Product CodeEHD
Date Received2018-09-12
Returned To Mfg2018-08-31
Model Number0.850.0021
Catalog Number0.850.0021
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARIBEX
Manufacturer Address11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-12

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