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 12/01/2016

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 occurred in the upper battery pack between the cells and printed circuit board (pcb).There was a blackening on the top of the upper battery pack and its printed circuit board (pcb).Cells 5 and 6 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 the event was a reportable event.However, during an investigation on 02/06/2017, it was determined that the event is reportable.A recall is ongoing.Reference z-2716/2717-2016.

Event Description

It was reported that the battery is giving red lights on the charger.The doctor noticed a burn mark on the inside of the cabinet where it looks like the battery exploded and is in the shape of the battery handset.No injuries, user or patient involvement were 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 ; 7045877240
• MDR Report Key: 6386346
• MDR Text Key: 69329393
• Report Number: 1017522-2017-00014
• 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: 12/01/2016

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: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2014
• 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