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

Model Number 0.850.00090

Device Problems Device Issue (2379); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

The battery handset was returned and is undergoing investigation.A follow-up report will be submitted upon completion of the investigation.Upon receipt of initial complaint, it was originally determined not to be reportable.However, upon further inspection, we have determined to report this event.Aribex initiated a recall, reference recall z2716/17-2016.

Event Description

It was reported that the battery caught fire.

Manufacturer Narrative

There was a blackening on the top of the upper battery pack and its printed circuit board (pcb).Only cell 4 appears to have been involved in the thermal runaway, likely by supplying energy into a fault in the board.Additionally there was a slight melting of the handset plastic enclosure.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 upper battery pack between the cells and pcb.This concludes our investigation.A recall is ongoing, reference z-2716/2717-2016.

• 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 ; 7045877241
• MDR Report Key: 6047738
• MDR Text Key: 58077531
• Report Number: 1017522-2016-00028
• 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,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.00090
• Device Catalogue Number: 0.850.0009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2013
• 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