MAUDE Adverse Event Report: ARIBEX NOMAD PRO 2; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 0.850.0025

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

The unit has not yet been returned for evaluation.The device will be evaluated in the country in which the event occurred.A follow-up report will be submitted upon completion of investigation.Upon receipt of the initial complaint, it was determined that this was not a reportable event.However, upon further review, we determined to report this event.Aribex initiated a recall, reference recall z2716/17-2016.

Event Description

It was reported that the battery ruptured.

Manufacturer Narrative

The unit has not been returned to the manufacture as damaged or potentially damaged lithium-ion batteries are restricted from air shipment transportation.It was anticipated that an evaluation would be conducted in this country, but an evaluation is not feasible.

• Brand Name: NOMAD PRO 2
• 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: 6048186
• MDR Text Key: 58132983
• Report Number: 1017522-2016-00031
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K081664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2016

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: 0.850.0025
• Device Catalogue Number: 0.850.0025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2016
• 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
• Date Device Manufactured: 08/17/2015
• 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