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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 Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 09/14/2017
Event Type  malfunction  
Manufacturer Narrative
The unit was returned and an evaluation was conducted. A visual inspection was conducted, use testing performed, as well as system testing to internal procedures. No failure was detected. This concludes the investigation.
 
Manufacturer Narrative
The unit has not been returned to the manufacturer for investigation, but it is anticipated that the user facility will return the unit. An evaluation will be performed once the unit is returned and a follow-up report submitted upon evaluation completion.
 
Event Description
It was reported that the unit is hot to touch, even the battery. The unit is not giving a cool down message. The unit shuts down after the first x-ray and sometimes after the second. It sometimes freezes. There was no report of injuries, 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 Key6948624
MDR Text Key254349473
Report Number1017522-2017-00056
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
Type of Report Initial,Followup
Report Date 11/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2017
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 Manufacturer10/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2009
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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