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U.S. Department of Health and Human Services

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

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ARIBEX NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number 0.850.0009
Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885); Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Date 10/10/2017
Event Type  malfunction  
Manufacturer Narrative
The unit was returned and an evaluation completed. The report of "system failure and device began to get hot to touch" cannot be confirmed. The evaluation determined that an internal cell failure had occurred. Although aribex determined that the initial report may have been a reportable event, there was no indication that the malfunction would contribute to a serious injury and therfore, would not be a reportable event. This concludes the investigation.
 
Manufacturer Narrative
The unit has not yet been returned to the manufacturer for an evaluation. If the unit is returned, an evaluation will be completed. A follow-up report will be submitted upon evaluation completion.
 
Event Description
It was reported that there was a system error message. The batteries were changed, two images were taken, and the back of the device began to get hot to touch. There was no report of injury, patient or user involvement and no impact to patient care.
 
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Brand NameNOMAD PRO
Type of DeviceEXTRAORAL 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 Key7011380
MDR Text Key248752860
Report Number1017522-2017-00065
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081664
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Dental Hygienist
Type of Report Initial,Followup
Report Date 12/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2017
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 Manufacturer12/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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