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

Model Number 0.850.0009

Device Problem Melted (1385)

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

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

The facility discarded the device component.Therefore, we are unable to perform an evaluation.

Event Description

It was reported that a nomad pro battery started to melt while attached to the charging cradle.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 (Section G): ARIBEX; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: erika martin ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877241
• MDR Report Key: 5779538
• MDR Text Key: 49832173
• Report Number: 1017522-2016-00018
• 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: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0009
• Device Catalogue Number: 0.850.0009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2011
• 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