• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 08/14/2018
Event Type  malfunction  
Manufacturer Narrative
The unit was returned and an engineering evaluation completed. Visual inspection shows signs of electrolyte leakage on the tube head plastic enclosure and a thermal event in lower battery pack. 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 was leaking a substance. The device had not been dropped. There was no report of patient or user injury, no patient or user involvement, and no impact to patient care.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7870400
MDR Text Key120105426
Report Number1017522-2018-00026
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 09/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2018
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 Manufacturer08/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-