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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARIBEX NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM

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ARIBEX NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number 0.850.0009
Device Problems Material Discolored (1170); Device Emits Odor (1425)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2016
Event Type  malfunction  
Manufacturer Narrative
Upon visual inspection is appears that a thermal event occurred. It is not possible to determine the exact sequence of events that led to the thermal event. However, there is evidence that a short occurred in the lower battery pack between the cells and printed circuit board (pcb) there was a blackening on the top of the lower battery pack and 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 our investigation. Upon initial receipt of the complaint aribex did not believe the event was a reportable event. However on 2/6/2017 during the initial investigation it was determined this event should be reportable. A recall is ongoing. Reference (b)(4).
 
Event Description
The customer reported that the outside of the nomad pro handset looked discolored and smelled a burning smell like a fire, but they did not see fire. There were no injuries reported.
 
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Brand NameNOMAD PRO
Type of DeviceEXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
ARIBEX
11727 fruehauf drive
charlotte NC 28273
Manufacturer (Section G)
ARIBEX
11727 fruehauf drive
charlotte NC 28273
Manufacturer Contact
erika martin
11727 fruehauf drive
charlotte, NC 28273
7045877241
MDR Report Key6382894
MDR Text Key69499790
Report Number1017522-2017-00009
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081664
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 12/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0009
Device Catalogue Number0.850.0009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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