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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 Problems Fire (1245); Melted (1385)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2014
Event Type  malfunction  
Event Description
Customer reported that the battery pack (handset) of the device caught fire while placed in a drawer and partially melted.
 
Manufacturer Narrative
The handset and the device were assembled on 17-oct-2011 and is about 3 years old.Expected end of life for the handset is 2 years or 300 charge/discharge cycles.The battery pack (handset) was beyond end of life since the battery was over 2 years old.Additional investigation is ongoing and a follow-up report will be submitted.
 
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Brand Name
NOMAD PRO
Type of Device
EXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
ARIBEX, INC.
744 south 400 east
orem UT 84651
Manufacturer Contact
sanjay ahuja
744 south 400 east
orem, UT 84097
2679541463
MDR Report Key4071212
MDR Text Key4900736
Report Number3005417494-2014-00001
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K935046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 08/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2014
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
Is the Reporter a Health Professional? No
Date Manufacturer Received07/24/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2011
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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