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U.S. Department of Health and Human Services

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

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AIRBEX NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number 0.850.0009
Device Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 02/09/2020
Event Type  malfunction  
Manufacturer Narrative
The device and handset have been returned and forwarded to engineering for evaluation. Engineering evaluation has not been completed to date. Once the engineering evaluation has been completed a subsequent report will be submitted, detailing the results of the evaluation performed to include the results and conclusion codes.
 
Event Description
It was reported by the customer that the nomad x-ray system handset melted over the weekend. There was no report of user or patient injury or impact to patient care. The reported device and handset have been returned for evaluation.
 
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Brand NameNOMAD PRO
Type of DeviceEXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
AIRBEX
11727 fruehauf drive
charlotte, nc
Manufacturer (Section G)
AIRBEX
11727 fruehauf drive
charlotte, nc
Manufacturer Contact
david waters
11727 fruehauf drive
charlotte, nc 
5877297
MDR Report Key9820640
MDR Text Key196103433
Report Number1017522-2020-00003
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 Dentist
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2009
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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