FDA.reportPublic FDA data

MAUDE MDR 7823266

MDR report key
7823266
Report number
1017522-2018-00024
Event key
0
Event type
3
Date of event
2018-02-09
Date received
2018-08-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. ERIKA MARTIN
Address
11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NOMAD PRO 2EXTRAORAL SOURCE X-RAY SYSTEMARIBEXEHD0.850.00220.850.0022Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-280

Event Narratives#

N

Patient 1

THE INITIAL INFORMATION RECEIVED BY THE DENTAL OFFICE DID NOT INDICATE THAT A SAFETY-RELATED EVENT HAD OCCURRED. THE BATTERY HANDSET WAS RETURNED TO THE MANUFACTURER ALMOST 90 DAYS AFTER THE REPORT. THE BATTERY HANDSET WAS TO BE DISPOSED OF AND DURING BATTERY AND HANDSET DISPOSAL ACTIVITY, IT WAS DETERMINED THAT THE BATTERIES MAY HAVE ENTERED INTO A THERMAL EVENT THAT WAS NOT KNOWN BY THE DENTAL OFFICE. AN ENGINEERING EVALUATION WAS CONDUCTED. UPON VISUAL INSPECTION IT APPEARS THAT A THERMAL EVENT OCCURRED. IT IS NOT POSSIBLE TO DETERMINE THE EXACT SEQUENCE OF EVENTS THAT LED TO THE THERMAL EVENT. HOWEVER, THERE IS EVIDENCE THAT A SHORT OCCURED IN THE LOWER BATTERY PACK BETWEEN THE CELLS AND PRINTED CIRCUIT BOARD. THERE WAS A BLACKENING ON THE TOP OF THE LOWER BATTERY PACK AND ITS PRINTED CIRCUIT BOARD (PCB). CELLS 2 AND 3 APPEAR TO HAVE BEEN INVOLVED IN THE THERMAL EVENT, LIKELY BY SUPPLYING ENERGY INTO A FAULT IN THE BOARD. ADDITIONALLY THERE WAS A SLIGHT MELTING OF THE HANDSET PLASTIC ENCLOSURE. THIS CONCLUDES THE INVESTIGATION.

D

Patient 1

IT WAS REPORTED THAT THE BATTERIES NO LONGER CHARGE. BATTERIES WERE PLACED ON NEW CHARGER AND NO LIGHTS COME ON FROM THE BATTERIES. THERE WAS NO REPORT OF INJURY, PATIENT OR USER INVOLVEMENT OR IMPACT TO PATIENT CARE. THERE WAS NO INDICATION OF A SAFETY-RELATED ISSUE BASED ON THE INFORMATION PROVIDED.