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

Model Number 0.850.0021

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the returned unit has been completed.Upon visual inspection, it appears that a thermal event occurred.The thermal event caused significant melting of the handset such that a complete analysis cannot be performed.It is not possible to determine the exact sequence of events that led to the thermal event.There is evidence that a short circuit occurred in the battery pack assembly.Lower battery pack of handset fused to handset pcb and melted plastic due to expansion and heating of lower battery pack, which also fused the handset to the charger.No apparent heating of upper battery pack.This concludes the investigation.A recall is ongoing.Reference z-2716/2717-2016.

Event Description

It was reported that the battery handle looks like it melted on the unit.There was no report of injury or user or patient involvement.

• 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: 6657963
• MDR Text Key: 78130231
• Report Number: 1017522-2017-00041
• 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: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0021
• Device Catalogue Number: 0.850.0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• 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