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 12/23/2014

Event Type  malfunction  

Event Description

The customer reported that the device handset casing was partially melted and the charging cradle had charring on the contacts.No injuries were reported.

Manufacturer Narrative

The device was assembled 30-april-2012.The initial incident was reported to the mfr on (b)(4) 2014.Based on the available info at that time, the incident was determined to be not reportable.Upon receipt and inspection of the device handset and charger, the date of awareness was established as (b)(4) 2014 and the determination was made to report this incident.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 thermal event was contained in the handset enclosure and no injuries were reported.The nomad pro operator manual warns users that connecting areas of the device are open to ingress, and damage may occur if cleaners are sprayed directly on the device.This concludes our investigation.

• Brand Name: NOMAD PRO
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): ARIBEX, INC.; orem UT
• Manufacturer Contact: sanjay ahuja ; 744 s 400 e; orem, UT 84097
• MDR Report Key: 4451339
• MDR Text Key: 22159457
• Report Number: 3005417494-2015-00001
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2014

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: FP-0005
• Device Catalogue Number: FP-0005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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