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

Model Number 0.850.0022

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

The device with handsets were returned and upon evaluation by engineering it was concluded that the complaint of the device taking images on it own was confirmed.Analysis shows that the root cause for this complaint is a dislodged trigger spring which allows false triggering.It appears that there has been an impact to the device such as being dropped.The trigger spring was dislodged from its original position.The device can fire on its own when it is jolted.This completes the evaluation.

Event Description

It was reported that the device was taking images on its own when moving to the next series.There was no report of user or patient injury or impact to patient care.The device was returned for evaluation.

• Brand Name: NOMAD PRO2
• 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: 9454165
• MDR Text Key: 194322651
• Report Number: 1017522-2019-00020
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• 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