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

Model Number 0.850.0021

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

Device has not yet been returned to manufacturer for investigation.A follow-up report will be submitted upon completion of investigation.

Event Description

It was reported that the there was a burning smell and facility found a hole in the side of the battery where the plastic had melted.

Manufacturer Narrative

Manufacturer attempting to obtain unit for investigation.A follow-up report will be submitted upon investigation completion.

Manufacturer Narrative

Attempts to obtain the unit back for an investigation have been unsuccessful.If the unit is returned, an evaluation will be performed and a follow-up report submitted upon evaluation completion.This concludes our investigation.

• 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: 6046149
• MDR Text Key: 58023021
• Report Number: 1017522-2016-00027
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: KO81664
• 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,Followup
• Report Date: 09/20/2016

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/19/2016; 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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