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 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation is not yet completed.A follow-up report will be submitted upon evaluation completion.Aribex initiated a field action that was classified as a class ii recall on 09/02/2016, reference recall z-2716/2717-2016.

Event Description

It was reported that a dental assistant had just put the battery to charge and approximately 30 minutes after, they noticed smoke coming out of the battery.The charger was unplugged and it continued to smoke more.With fear of the battery exploding, the battery and charger were placed outside.The battery was not in use at the time.There were no patient or operator injuries or property damage reported.

Manufacturer Narrative

Upon visual inspection, it appears that a thermal runaway occurred.The thermal event caused significant melting of the handset such that a complete rca 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 circuit occurred in the battery pack assembly.The lower battery pack of handset melted the plastic due to expansion and heating of the battery pack.The heat from the lower pack caused the upper battery pack to heat also and fused to the 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: 6161920
• MDR Text Key: 62233707
• Report Number: 1017522-2016-00043
• 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: Dental Assistant
• Type of Report: Initial,Followup
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• 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: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2010
• 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