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

Model Number 0.850.0021

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

Aribex determined at the time of the report by the facility, that the event was not reportable.Following an engineering review on 3/15/2017, aribex has determined that this is a reportable event.An evaluation of the returned unit has been 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 pcb.There was 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.A recall is ongoing.Reference z-2716/2717-2016.

Event Description

It was reported that the battery stopped working.The facility was able to use the other battery and there was no downtime.There was no report of patient or user involvement, injuries, or impact to patient care.There was no damage reported.

• Brand Name: NOMAD PRO 2
• Type of Device: EXTRAORAL 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 Key: 6453881
• MDR Text Key: 71578595
• Report Number: 1017522-2017-00026
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0021
• Device Catalogue Number: 0.850.0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1