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

Model Number 0.850.0022

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

Device not yet received by manufacturer.Once received, an evaluation will be performed and a follow-up report submitted after evaluation completion.

Event Description

It was reported that the battery handset was on the charger during the morning and while on the charger, the battery started burning and melted on the charger.There was no patient or operator involvement and no injuries reported.The unit was not in use at the time of the event and there was no impact to patient care.It was also reported that there is discoloration on the cabinet where the unit was located at the time the event occurred.

Manufacturer Narrative

Providing correct engineering evaluation: upon visual inspection it appears that a thermal event occurred.The thermal event caused significant melting of the handset such that a complete root cause analysis cannot be performed.It is not possible to determine the exact sequence of events that led to the thermal event.There is evidence that a short occurred in the battery pack assembly.The lower battery pack of the handset fused to the handset printed circuit board and melted plastic due to expansion and heating of the lower battery pack, which also fused the handset to the charger.There was no apparent heating of the upper battery pack.This concludes the investigation.A recall is ongoing.Reference z-2716/2717-2016.

Manufacturer Narrative

The unit was returned ion 1/26/2017 by the customer as part of a different return authorization and was not recognized until 3/15/2017.An engineering evaluation has been completed.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 occurred 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 the investigation.A recall is ongoing.Reference z-2716/2717-2016.

• Brand Name: NOMAD PRO 2
• 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: 6249165
• MDR Text Key: 64767585
• Report Number: 1017522-2017-00002
• 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,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0022
• Device Catalogue Number: 0.850.0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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