MAUDE Adverse Event Report: ARIBEX NOMAD PRO 2; EXTRAORAL SOURCE X-RAY SYAYTEM

Model Number 0.850.0021

Device Problems Melted (1385); Nonstandard Device (1420); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

The unit has been returned to the manufacturer and investigation has not yet been completed.A follow-up report will be submitted upon investigation completion.Refer to recall z2716/2717-2016.

Event Description

It was reported that the battery and charger melted.

Manufacturer Narrative

Upon visual inspection it appears that a thermal runaway 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.There was a blackening on the top of the lower battery pack and its printed circuit board (pcb).Only cell 3 appears 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 out investigation.A recall is ongoing, reference z-2716/2717-2016.

• Brand Name: NOMAD PRO 2
• Type of Device: EXTRAORAL SOURCE X-RAY SYAYTEM
• 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: 6127752
• MDR Text Key: 61189368
• Report Number: 1017522-2016-00040
• 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: 10/26/2016

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: 0.850.0021
• Device Catalogue Number: 0.850.0021
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2015
• 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