MAUDE Adverse Event Report: ARIBEX NOMAD PRO; EXTRAORAL SOURCE XRAY SYSTEM

Model Number 0.850.0009

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

Device has been returned and will undergo evaluation.A follow-up report will be submitted after evaluation completion.Reference recall z-2716/2717-2016.

Event Description

It was reported that the battery was on the counter not connected to anything, hot to touch, and blew up on the counter.No one was injured.Battery acid on the counter was cleaned up.

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 upper 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 5 and 6 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 XRAY 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: 6248143
• MDR Text Key: 64720595
• Report Number: 1017522-2016-00045
• 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: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2009
• 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