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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARIBEX NOMAD PRO 2 EXTRAORAL SOURCE X-RAY SYSTEM

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ARIBEX NOMAD PRO 2 EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number 0.850.0021
Device Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 06/22/2018
Event Type  malfunction  
Manufacturer Narrative
The initial report did not indicate that a potential thermal runaway event occurred and thus, was not deemed a reportable event. Upon further investigation, a visual inspection was conducted and it 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 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.
 
Event Description
It was reported that the unit has a cracked case. There was no report of injury, user or patient involvement. There was no report of impact to patient care.
 
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Brand NameNOMAD PRO 2
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
MDR Report Key7706425
MDR Text Key114587350
Report Number1017522-2018-00021
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 Dentist
Type of Report Initial
Report Date 07/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0021
Device Catalogue Number0.850.0021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2014
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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