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 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

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 circuit occurred in the lower battery pack between the cells and printed circuit board (pcb).There was a blackening on the top of the lower battery pack and its pcb.Cells 1,2, 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.Upon initial receipt of the complaint, aribex did not believe that the event was a reportable event.However, on 02/06/2017, an investigation determined the event to be reportable.A recall is ongoing.Reference recall z-2016/2017-2016.

Event Description

It was reported that the battery handle was put in a cabinet over the weekend.There was a smell of burnt plastic.The battery handle melted and was not on anything.There was no report of injuries, patient or user involvement.

• 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
• MDR Report Key: 6385655
• MDR Text Key: 69373894
• Report Number: 1017522-2017-00010
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• 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: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2014
• 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