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U.S. Department of Health and Human Services

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

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ARIBEX NOMAD PRO HANDHELD X-RAY SYSTEM EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
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.
 
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Brand NameNOMAD PRO HANDHELD X-RAY SYSTEM
Type of DeviceEXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
ARIBEX
11727 fruehauf drive
charlotte NC 28273
MDR Report Key7630291
MDR Text Key112474314
Report Number1017522-2018-00020
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
PMA/PMN Number
K081664
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0009
Device Catalogue Number0.850.0009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

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