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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 0.850.0022
Device Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 09/27/2017
Event Type  malfunction  
Manufacturer Narrative
The unit was returned and an evaluation was completed. Upon visual inspection, 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 occurred 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 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 completes the investigation.
 
Event Description
It was reported that the battery was on the charging cradle overnight and when the office returned to work, a melting plastic smell was noticed, which was the battery melting. The charging cradle looks as if the battery melted on it. There was no report of injuries, patient or user involvement, or 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
7045877241
MDR Report Key6963288
MDR Text Key90657753
Report Number1017522-2017-00057
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 10/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2016
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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