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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARIBEX NOMAD PRO 2 EXTRAORAL SOURCE X-RAY SYSTEM

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ARIBEX NOMAD PRO 2 EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number 0.850.0022
Device Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 07/06/2017
Event Type  malfunction  
Manufacturer Narrative
The unit was received and an evaluation conducted. The evaluation determined that the printed circuit board showed signs of corrosion that caused a short circuit on the handset control printed circuit board. Aribex determined that this is not a reportable event. The unit was repaired and sent back to the dental office. This completes the investigation.
 
Manufacturer Narrative
The unit was returned for evaluation 111 days after the initial report. An evaluation is anticipated. The initial report did not indicate that a reportable event had occurred. A follow-up report will be submitted upon evaluation completion.
 
Event Description
It was reported that the battery is not charging and that the charging cradle of the unit might be a problem. When the battery handset was received, there was a note stating the handset had caught on fire. There was no report of injury, patient or user involvement or impact to patient care.
 
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Brand NameNOMAD PRO 2
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 Key7069668
MDR Text Key258697699
Report Number1017522-2017-00067
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 12/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0022
Device Catalogue Number0.850.0022
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/05/2017
Was Device Evaluated by Manufacturer? Yes
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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