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

Model Number 0.850.0009

Device Problems Thermal Decomposition of Device (1071); Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

Unit has not yet been returned for investigation.A follow-up report will be submitted upon investigation.A recall has been initiated, reference (b)(4).

Event Description

It was reported that there was a burning smell coming from the unit.

Manufacturer Narrative

Unit received by manufacturer on 11/28/2016 and will undergo investigation.A follow-up report will be submitted upon investigation completion.

Manufacturer Narrative

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 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 lower 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: 6059178
• MDR Text Key: 58845337
• Report Number: 1017522-2016-00035
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/01/2016; 02/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1