MAUDE Adverse Event Report: AIRBEX NOMAD DENTAL 60KV; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 0.850.0000

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

The unit was returned to the manufacture and an evaluation was conducted.Two batteries and charger were returned with the device.No issues were found with the charger and battery# 2.Physically, the device exhibited surface cracks around the display and a missing end cap.The device was manufactured in march of 2007 and it appears that it has been used extensively.The end cap was missing, and visual inspection showed that the battery terminals inside the device and one battery were overheated.Analysis of the battery contacts showed that they shorted together causing a large surge of energy to dissipate there when a battery was inserted.This caused the blackening of the printed circuit board and of the battery.The battery#1 became hot.There is evidence of heat damage, possibly due to fire.Therefore, the initial complaint of "device caught on fire" is confirmed.It is unknown if the contacts became shorted because of the unit being dropped or if they weakened over time from repeated use.The shorting of the contacts caused the negative and positive battery terminals to touch, causing a short.This was the occurrence that lead to the thermal event.This concludes the evaluation.

Event Description

It was reported that the nomad x-ray system caught fire.The nomad x-ray system was reported to have started smoking while on the counter and when the battery was removed flames erupted.There was no report of user or patient injury or impact to patient care.The device was returned for evaluation.

• Brand Name: NOMAD DENTAL 60KV
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): AIRBEX; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): AIRBEX; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: david waters ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877297
• MDR Report Key: 8975474
• MDR Text Key: 202552612
• Report Number: 1017522-2019-00014
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0000
• Device Catalogue Number: FP 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2007
• 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