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

Model Number NOMAD PRO

Device Problem Smoking (1585)

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

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation of the returned device has been completed.Our records indicate that the device was manufactured in june 2009.The unit was inspected and it was determined that there was excessive cleaner on the handset plastic covers.There was a battery thermal runway, which lead to battery failure in the device.The investigation found evidence of heavily applied dental office cleaners and fluid ingress into the interior of the handset.No injuries were reported.The nomad pro operator manual 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 concludes our investigation.

Event Description

The customer reported the nomad pro started smoking during use.There were no injuries reported.

• Brand Name: NOMAD PRO
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): ARIBEX; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: erika martin ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877241
• MDR Report Key: 5318343
• MDR Text Key: 34785987
• Report Number: 1017522-2015-00024
• 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: Dentist
• Type of Report: Initial
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• Device Model Number: NOMAD PRO
• Device Catalogue Number: 0.850.0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• 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