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 Type  malfunction  

Manufacturer Narrative

The unit has not yet been returned to manufacturer for investigation.A follow-up report will be submitted when unit is received and evaluated.(b)(4) initiated a recall that was classified by fda on 09/02/2016.Please reference recall z-2716/2717-2016.

Event Description

It was reported that when the batteries were on the unit and removed from unit there were sparks coming from the handset.When they went to walk the battery outside it began smoking.Reporting office is unsure of exact date of event, possibly (b)(6) 2016, but reported the event to (b)(4) on (b)(6) 2016.It was reported that there was no patient or operator involvement or injuries.

Manufacturer Narrative

An evaluation of the unit determined that it appears the handset control printed circuit board exhibited some signs of corrosion.It is unclear why this happened.It appears corrosion is the cause of the short circuit.The battery was not affected in this handset.There was no sign of a thermal event.This concludes the investigation.Based upon this information, the company has determined that this is not a reportable event.

• 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: 6153587
• MDR Text Key: 61710485
• Report Number: 1017522-2016-00042
• 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
• Report Date: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• 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: 03/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2012
• 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