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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 08/21/2017
Event Type  malfunction  
Manufacturer Narrative
Upon receipt of the complaint, it was initially determined that this event was not reportable and the battery handset of the unit was replaced. Upon further review of the complaint, it was determined that this is a reportable event. The battery handset subject of the reported incident was discarded by the facility. No evaluation was conducted since the battery handset of the unit has been discarded. This concludes the investigation.
 
Event Description
It was reported that the battery is from 2015 and was sitting in a box not being used. When it was removed from the box, it had burst and has a hole in the side of the casing. There was no report of injuries, user or patient involvement, and no 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 Key7061949
MDR Text Key93226969
Report Number1017522-2017-00066
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 Dental Assistant
Type of Report Initial
Report Date 11/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dental Assistant
Device Model Number0.850.0021
Device Catalogue Number0.850.0021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2015
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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