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U.S. Department of Health and Human Services

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

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DENTAL IMAGING TECHNOLOGIES CORPORATION 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 04/14/2020
Event Type  malfunction  
Manufacturer Narrative
Visual evaluation shows the condition of the unit received from the field. Upon visual inspection a thermal event did occur. It is not possible to determine the exact sequence of events that led to the thermal event. Based on previous investigations with the same type of battery, a short may have occurred in the upper battery pack between the cells and printed circuit. The part and lot number of the hand held unit. Based on the serial number sequence, the battery was manufactured september 9, 2015. According to our records, the handset battery handle assy was manufacture february 9, 2016. Based on the visual inspection of the printed circuit board, thermal damage involved charring on the printed circuit board. Due to the melting of the plastic, it is difficult to remove the printed circuit board for further investigation. The plastic encasing has melted away from the area containing the battery pack. Any further investigation in this area cannot be completed due to the damage. The upper battery pack is still enclosed in the handle section of the handset. Visual evaluation of the handle section leads us to believe that the upper battery pack was not involved in the thermal event. The cell pouches of the lower battery pack were completely destroyed by thermal event, exposing and fusing two of the three the electrodes. With the absence of the cell pouch it cannot be determined if electrolyte leakage contributed to the thermal event. Based on previous investigations with the same type of battery, a electrolyte leakage could have occurred. This completes the investigation.
 
Event Description
Battery caught on fire on the charging cradle - no impact to patient care. No injury reported.
 
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Brand NameNOMAD PRO
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 
9540270
MDR Report Key10098528
MDR Text Key200829219
Report Number2530069-2020-00001
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 05/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2020
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 Manufacturer04/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2011
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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