MAUDE Adverse Event Report: ARIBEX NOMAD PRO2; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 0.850.0025

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

The photo provided by the complainant confirmed a small hole approximately 1 cm in diameter, in the side of the handset.The handset was not returned, and no evaluation was performed.This concludes the investigation.

Event Description

It was reported that the handset battery exploded during charging, resulting in a small hole approximately 1 cm in diameter in the plastic enclosure of the handset.There was no report of injuries, patient or user involvement, and no impact to patient care.The reported handset was not returned for evaluation due to international laws restricting air freight of faulty lithium ion batteries.

• Brand Name: NOMAD PRO2
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): ARIBEX; 11727 fruehauf drive; charlotte, nc
• Manufacturer (Section G): ARIBEX; 11727 fruehauf drive; charlotte, nc
• Manufacturer Contact: david waters ; 11727 fruehauf drive; charlotte, nc ; 5877297
• MDR Report Key: 9733047
• MDR Text Key: 198540539
• Report Number: 1017522-2020-00002
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: BA
• 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
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• 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: FP 0190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2017
• 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