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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 Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 02/08/2018
Event Type  malfunction  
Manufacturer Narrative
Upon visual inspection, it appeared that a thermal event occurred. It was 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. Cells 2 and 3 appeared 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. The unit was repaired and returned to customer. This concludes the investigation.
 
Event Description
Customer returned unit to aribex for an annual evaluation. There was no report of injuries or impact to patient care. There was no indication of a product problem at the time of the initial report. The unit was evaluated on 02/08/2018 by a repair technician. During the evaluation, the technician determined that a battery handset required further investigation.
 
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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 Key7307061
MDR Text Key101511143
Report Number1017522-2018-00007
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
081664
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Dentist
Type of Report Initial
Report Date 03/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0009
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2012
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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