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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 0.850.0021
Device Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 09/22/2017
Event Type  malfunction  
Manufacturer Narrative
The unit has not been returned after attempts to obtain the unit and no evaluation is able to be completed. The report of "batteries are hot to touch" cannot be confirmed. The investigation is closed.
 
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 received and a follow-up report submitted upon evaluation completion.
 
Event Description
It was reported that the batteries are hot to touch. There was no report of injuries, 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 Key6965819
MDR Text Key250176685
Report Number1017522-2017-00058
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0021
Device Catalogue Number0.850.0021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2016
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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