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 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

The unit was returned for evaluation 111 days after the initial report.An evaluation is anticipated.The initial report did not indicate that a reportable event had occurred.A follow-up report will be submitted upon evaluation completion.

Event Description

It was reported that the battery is not charging and that the charging cradle of the unit might be a problem.When the battery handset was received, there was a note stating the handset had caught on fire.There was no report of injury, patient or user involvement or impact to patient care.

Manufacturer Narrative

The unit was received and an evaluation conducted.The evaluation determined that the printed circuit board showed signs of corrosion that caused a short circuit on the handset control printed circuit board.Aribex determined that this is not a reportable event.The unit was repaired and sent back to the dental office.This completes the 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: 7069668
• MDR Text Key: 93896773
• Report Number: 1017522-2017-00067
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• 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?: Yes
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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