FDA.reportPublic FDA data

MAUDE MDR 7706425

MDR report key
7706425
Report number
1017522-2018-00021
Event key
0
Event type
3
Date of event
2018-06-22
Date received
2018-07-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
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 SYSTEMARIBEXEHD0.850.00210.850.0021Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-200

Event Narratives#

N

Patient 1

THE INITIAL REPORT DID NOT INDICATE THAT A POTENTIAL THERMAL RUNAWAY EVENT OCCURRED AND THUS, WAS NOT DEEMED A REPORTABLE EVENT. UPON FURTHER INVESTIGATION, A VISUAL INSPECTION WAS CONDUCTED AND 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 UNIT HAS A CRACKED CASE. THERE WAS NO REPORT OF INJURY, USER OR PATIENT INVOLVEMENT. THERE WAS NO REPORT OF IMPACT TO PATIENT CARE.