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

Model Number 0.850.0009

Device Problems Radiation Overexposure (3017); Radiation Output Problem (4026)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

The unit was returned and an initial evaluation was conducted.It was determined the unit may be emitting radiation while the power is on, but further investigation is needed.No conclusions have been made as the evaluation is ongoing.A follow-up report will be submitted after the completion of the evaluation.

Event Description

It was reported that the unit is not powering down and the battery must be removed to power off.The radiation lights turn orange as if the device is taking exposures on its own.There was no report of injuries, patient or user involvement ot impact to patient care.

Manufacturer Narrative

A through evaluation of the returned unit was completed.There was no visible damage to the unit exterior.There were no visible (with magnification) issues with circuts boards, solder, wires, cables or connectors.The lcd, led and audio all indicate active x-ray.One or more of the indications remain active after trigger is released.There were no observed electrical anomalies (open, shorts, degraded components, high reistance conditions, intermittent conditions, etc.).While taking an x-ray, the unit becomes unresponsive.Unit enables and initiates x-ray normally.The lcd, led and audio all indicate active x-ray.One or more of the indications remain active after trigger is released.Unit does not respond to further button/trigger actions.Handset must be removed to power off unit.Root cause indeterminate, although inducing problem by shaking suggests electromechanical issue.The unit was not repaired and will be scrapped.This concludes the investigation.

• Brand Name: NOMAD PRO HANDHELD X-RAY SYSTEM
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): ARIBEX; 11727 fruehauf drive; charlotte NC 28273
• MDR Report Key: 7630291
• MDR Text Key: 112474314
• Report Number: 1017522-2018-00020
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K081664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

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: 0.850.0009
• Device Catalogue Number: 0.850.0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1