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

Model Number FP-0005

Device Problem Battery Problem (2885)

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

Event Date 04/16/2015

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

The device has been returned to manufacturer on 04/28/2015.Investigation is ongoing.A f/u report will be filed upon completion of investigation.

• Brand Name: NOMAD PRO
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): ARIBEX, INC.; orem UT
• Manufacturer Contact: sanjay ahuja ; 11729 fruehauf dr.; charlotte, NC 28273
• MDR Report Key: 4777684
• MDR Text Key: 5779293
• Report Number: 1017522-2015-00007
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FP-0005
• Device Catalogue Number: FP-0005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1