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 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

The initial report did not indicate that the suspect device experienced a malfunction that would be a reportable event.After an initial visual inspection of the device, it was determined that the event that occurred is reportable and an evaluation was conducted.Upon visual inspection it appears that a thermal event 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 printed circuit board.There was a blackening on the top of the upper 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 the investigation.

Event Description

It was reported that the office is receiving a system failure message with every battery that they put on the unit.There was no report of injuries, or patient or user involvement.

• 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: 6901728
• MDR Text Key: 87746354
• Report Number: 1017522-2017-00053
• 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
• Report Date: 09/28/2017

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: Health Professional
• Device Model Number: 0.850.0022
• Device Catalogue Number: 0.850.0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• 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