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 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been received and is undergoing evaluation.A follow-up report will be submitted upon evaluation completion.A recall is currently ongoing.Refer to z-2716/2717-2016.

Event Description

It was reported that there was a burn smell.The handset had been left on the cradle overnight and the next morning had burn marks, but had not melted.Customer stated that the handset had been giving red lights for a bout a week prior to this event.There were no reports of injuries, or patient or user involvement.There was no report of any impact to patient care.

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 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 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.(b)(4).

• 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: 6598551
• MDR Text Key: 76203137
• Report Number: 1017522-2017-00031
• 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,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Device Unattended
• 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: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2013
• 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