MAUDE Adverse Event Report: ARIBEX, INC. NOMAD PRO; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number FP-0005

Device Problem Insufficient Heating (1287)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Customer indicated that the device contact broke and the device battery was left on the unit overnight and was partially burned when found.

Manufacturer Narrative

The handset was received and inspected where it was determined that 2 small holes (approximately 1/2 inch in diameter) had been burned through the bottom of the handset.Our records indicate that the handset and device were assembled in (b)(6) 2012 and are about 2 years old.Expected end of life for the handset is 300 charge/discharge cycles as per the user manual.Upon further inspection, it was determined that the battery experienced a thermal runaway which led to a battery failure in the device.This failure burned the small holes (approximately 1/2 inch in diameter) in the bottom of the handset.There was no damage to the surroundings and there were no pt injuries reported.This completes our investigation.

• 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 Key: 4181161
• MDR Text Key: 5022643
• Report Number: 3005417494-2014-00002
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FP-0005
• Device Catalogue Number: FP-0005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1