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

Model Number 0.850.0009

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

The analysis of the returned device has been completed.Our records indicate that the device was assembled in (b)(6) 2010.The returned unit was inspected visually and by x-ray.The investigation found evidence of heavily applied dental office cleaners and fluid ingress into the interior of the handset.It was determined that there was a short circuit in the lower battery pack circuit board that lead to the battery failure.No injuries were reported.The nomad operator manual provides instructions on the proper care, cleaning, and maintenance of the device.This concludes our investigation.Aribex initiated a recall, reference recall z2716/17-2016.

Event Description

It was reported by the customer that the battery was put on the charger and it started smoking.

Manufacturer Narrative

An additional evaluation has been completed.Upon visual inspection it appears that a terminal 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 printed circuit board (pcb).There was a blackening on the top of the lower battery pack and its 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.(b)(4).

• Brand Name: NOMAD PRO
• 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 28278
• Manufacturer Contact: mrs. ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877241
• MDR Report Key: 6042444
• MDR Text Key: 57921645
• Report Number: 1017522-2016-00025
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0009
• Device Catalogue Number: 0.850.0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1