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

Model Number 0.850.0009

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

The unit has not yet been returned to the manufacturer for an evaluation.If the unit is returned, an evaluation will be completed.A follow-up report will be submitted upon evaluation completion.

Event Description

It was reported that there was a system error message.The batteries were changed, two images were taken, and the back of the device began to get hot to touch.There was no report of injury, patient or user involvement and no impact to patient care.

Manufacturer Narrative

The unit was returned and an evaluation completed.The report of "system failure and device began to get hot to touch" cannot be confirmed.The evaluation determined that an internal cell failure had occurred.Although aribex determined that the initial report may have been a reportable event, there was no indication that the malfunction would contribute to a serious injury and therfore, would not be a reportable event.This concludes the investigation.

• 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: 7011380
• MDR Text Key: 92517600
• Report Number: 1017522-2017-00065
• 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: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2012
• 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