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U.S. Department of Health and Human Services

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

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AIRBEX NOMAD PRO2 EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
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.
 
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Brand NameNOMAD PRO2
Type of DeviceEXTRAORAL 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 Key9454165
MDR Text Key194322651
Report Number1017522-2019-00020
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081664
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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