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 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

The unit has been received and will undergo an investigation.A follow-up report will be submitted upon investigation completion.A recall has been ongoing, refer to z-2716/2717-2016.

Event Description

It was reported that the battery handset melted on the charger and burned the cabinet it was stored in.The outside of the battery has a melted hole in it.It burned from the inside out.Nothing caught on fire but there are brown char marks in the cabinet that come out from the sides of where the charger was sitting and the battery was very hot.The unit was not being used for diagnosis or treatment at the time of the event.There was no patient or user involvement and no injuries reported.There was no reported impact to patient care.

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).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 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: 6301242
• MDR Text Key: 66548341
• Report Number: 1017522-2017-00003
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

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: Device Unattended
• Device Model Number: 0.850.0009
• Device Catalogue Number: 0.850.0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2009
• 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