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

Model Number NOMAD PRO

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

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

Event Date 06/16/2015

Event Type  malfunction  

Event Description

The customer reported that the device handset and the charging cradle were partially melted and charred.No injuries were reported.

Manufacturer Narrative

Device return is anticipated but not yet received.Investigation will be completed within 30 days of return of the device, and a follow-up report will be filed upon completion.No user or pt injuries was reported.

Manufacturer Narrative

The investigation of the returned device has been completed.Our records indicate that the handset and the device was assembled in april 2012 and are more than 2 years old.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 failure resulted in partially melted and charred housing of the handset and the charging cradle.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.No injuries were reported.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 concludes 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: 4918212
• MDR Text Key: 6026203
• Report Number: 1017522-2015-00014
• 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: User Facility,Distributor,distributor,user facili
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NOMAD PRO
• Device Catalogue Number: 0.850.0009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2012
• 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