FDA.reportPublic FDA data

MAUDE MDR 5249665

MDR report key
5249665
Report number
5249665
Event key
0
Event type
3
Date of event
2015-08-21
Date received
2015-11-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CS8100SYSTEM,X-RAY,EXTRAORAL SOURCE,DIGITALCARESTREAM HEALTH, INC.MUHCS8100R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-250

Event Narratives#

N

Patient 1

D

Patient 1

THE MACHINE WAS INSTALLED BY THE VENDOR AND THE WIRING FROM THE MACHINE TO THE VISUAL CUE (X-RAY IN USE) WAS INSTALLED BY AN UNKNOWN CONTRACTOR. WHEN THE MACHINE WAS BEING ADJUSTED FOR THE PATIENT, IT SEEMS TO HAVE PULLED THE ENERGIZED WIRES AWAY FROM THE INTERNAL CIRCUIT BOARD CAUSING IT TO SHORT. THE ELECTRICAL SHORT CAUSED SMOKE AND SPARKS WHICH WERE WITNESSED BY THE CLINICAL TEAM. MANUFACTURER RESPONSE FOR CARESTREAM DENTAL PANOREX X-RAY MACHINE, (BRAND NOT PROVIDED) (PER SITE REPORTER): UNKNOWN.