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

Model Number NOMAD PRO

Device Problems Melted (1385); Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

Device has been returned and undergoing investigation.A follow-up report will be submitted upon completion.

Event Description

The customer reported that the device battery handset gave off an odor and was partially melted.No injuries were reported.

Manufacturer Narrative

The investigation of the returned device has been completed.Our records indicate that the device was manufactured in may 2008 and the battery handset was manufactured in august 2014.The expected end of life for the battery handset is 300 charge/discharge cycles per the user manual.The unit was inspected and it was determined that the battery experienced a thermal runway which led to a battery failure in the device.This battery handset enclosure was not compromised.No injuries or damage to the surrounding were reported.The investigation found evidence of heavily applied dental office cleaners and fluid ingress into the interior of the handset which resulted in a thermal event.The nomad pro operator manual (mp-0074 rev e) provides the following warning: "do not spray disinfectant or cleaners directly on the nomad pro, handsets, charging cradle or ac power supply.The connecting areas are open to ingress and damage to your device may result." this completes our investigation.

• Brand Name: NOMAD PRO
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): ARIBEX; 11727 fruehauf dr.; charlotte NC 28273
• Manufacturer Contact: sanjay ahuja ; 11727 fruehauf dr.; charlotte, NC 28273 ; 2679541463
• MDR Report Key: 4995517
• MDR Text Key: 24145898
• Report Number: 1017522-2015-00015
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dental Assistant
• Type of Report: Followup
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: NOMAD PRO
• Device Catalogue Number: 0.850.0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2008
• 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