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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 02/09/2018
Event Type  malfunction  
Manufacturer Narrative
The initial information received by the dental office did not indicate that a safety-related event had occurred. The battery handset was returned to the manufacturer almost 90 days after the report. The battery handset was to be disposed of and during battery and handset disposal activity, it was determined that the batteries may have entered into a thermal event that was not known by the dental office. An engineering evaluation was conducted. 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 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 batteries no longer charge. Batteries were placed on new charger and no lights come on from the batteries. There was no report of injury, patient or user involvement or impact to patient care. There was no indication of a safety-related issue based on the information provided.
 
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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 Key7823266
MDR Text Key118550473
Report Number1017522-2018-00024
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 Other Health Care Professional
Type of Report Initial
Report Date 08/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0022
Device Catalogue Number0.850.0022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2015
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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