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 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

Upon receipt of the complaint, it was initially determined that this event was not reportable and the battery handset of the unit was replaced.Upon further review of the complaint, it was determined that this is a reportable event.The battery handset subject of the reported incident was discarded by the facility.No evaluation was conducted since the battery handset of the unit has been discarded.This concludes the investigation.

Event Description

It was reported that the battery is from 2015 and was sitting in a box not being used.When it was removed from the box, it had burst and has a hole in the side of the casing.There was no report of injuries, user or patient involvement, and no impact to patient care.

• 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: 7061949
• MDR Text Key: 93226969
• Report Number: 1017522-2017-00066
• 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
• Report Date: 11/27/2017

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: Dental Assistant
• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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