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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARIBEX, INC. NOMAD PRO; EXTRAORAL SOURCE X-RAY SYSTEM
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ARIBEX, INC. NOMAD PRO; EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number FP-0005
Device Problem Battery Problem (2885)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2015
Event Type  malfunction  
Event Description
The customer reported that the device handset had melted onto the charging cradle.No injuries were reported.
 
Manufacturer Narrative
The device was manufactured in 09/2012.The device was returned to the manufacturer for investigation on 01/26/2015.Investigation of the device found evidence of heavily applied dental office cleaners and fluid ingress into the interior of the handset which resulted in a thermal event.The thermal event was contained in the handset enclosure and no injuries were reported.The nomad pro operator manual warns users that connecting areas of the device are open directly on the device.This concludes our investigation.
 
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Brand Name
NOMAD PRO
Type of Device
EXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
ARIBEX, INC.
orem UT
Manufacturer Contact
sanjay ahuja
744 south 400 east
orem, UT 84097
2679541463
MDR Report Key4535836
MDR Text Key5514186
Report Number3005417494-2015-00002
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
Reporter Occupation Dentist
Type of Report Initial
Report Date 01/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFP-0005
Device Catalogue NumberFP-0005
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/26/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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