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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTAL IMAGING TECHNOLOGIES CORPORATION NOMAD PRO2 EXTRAORAL SOURCE X-RAY SYSTEM

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DENTAL IMAGING TECHNOLOGIES CORPORATION NOMAD PRO2 EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number 0.850.0021
Device Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
Visual evaluation shows the condition of the unit received from the field. Upon visual investigation of the unit, it was concluded that a thermal event did take place resulting in the appearance of the affected unit. Investigation of the unit revealed that the thermal event started at the lower battery cell and migrated upward in the handset. The extent of the thermal event which resulted in the information to be illegible and unreadable, the plastic of the housing melting and losing its form and integrity, and observable thermal damage to the battery interface board resulting in difficulty of removing of the battery interface board for further investigation. The plastic of the handset / housing has melted away from the area containing the battery pack. Any further investigation in this area cannot be performed due to the damage. This completes the investigation. This device and associated malfunction was subject to a class 2 recall (z-2016/2017-2016) and was initiated by the original manufacturer, kavo dental technologies, llc dba aribex located in (b)(4), on april 1, 2016. The recall was initiated due to potential thermal events from batteries in the device handsets. The recall was terminated by fda on july 26, 2017. Aribex notified all customers of the recall while the recall was open. This particular customer responded back to aribex on november 3, 2016 and acknowledged the recall but did not want to replace this handset. This particular device was returned to dental imaging technologies corporation on december 14, 2020 for complaint investigation and as a result the handset was replaced. The battery has an expected service life of 1-2 years and the user did not follow the operators manual recommendations of service replacement of the handset batteries. Note: nomad device manufacturing has been moved from kavo dental technologies, llc dba aribex in (b)(4) to dental imaging technologies corporation in (b)(4) in march 2020.
 
Event Description
Handset caught on fire. No impact to patient care. No injury reported.
 
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Brand NameNOMAD PRO2
Type of DeviceEXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
DENTAL IMAGING TECHNOLOGIES CORPORATION
1910 north penn road
hatfield, pa
Manufacturer (Section G)
DENTAL IMAGING TECHNOLOGIES CORPORATION
1910 north penn road
hatfield, pa
Manufacturer Contact
al myers
1910 north penn road
hatfield, pa 
MDR Report Key11057201
MDR Text Key242900248
Report Number2530069-2020-00002
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
Report Date 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.850.0021
Device Catalogue NumberFP 0150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2013
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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