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 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

The unit was returned and an evaluation wsa conducted. 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 occured in the lower battery pack between the cells and the printed circuit control 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.

Event Description

It was reported that the batteries are making a burning smell when placed onto the cradle. The reporter was unsure if it is the cradle or the battery. There was no report of injury, patient or user involvement, or impact to patient care.

• 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 28273
• Manufacturer Contact: erika martin ; 11727 fruehauf drive; charlotte, NC 28273
• MDR Report Key: 7792661
• MDR Text Key: 117435712
• Report Number: 1017522-2018-00023
• 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
• Report Date: 08/15/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0.850.0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse