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

Model Number 0.850.0009

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

The unit has not yet been returned to the manufacturer for evaluation.A follow-up will be submitted upon investigation completion.Upon receipt of the initial complaint it was determined that this was not a reportable event.However, upon further review, we determined to report the event.Aribex initiated a recall, reference (b)(4).

Event Description

It was reported that the battery and cradle melted together while the battery was on the charger charging.

Manufacturer Narrative

Device not returned for evaluation as damaged lithium ion batteries are restricted from air shipment transportation.An evaluation is not possible at the manufacture site.Not returned.

• 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: 6048424
• MDR Text Key: 58135507
• Report Number: 1017522-2016-00033
• 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,Followup,Followup
• Report Date: 09/15/2016

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: 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
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/20/2016; 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1