MAUDE MDR 1076163

MDR report key
1076163
Report number
9617251-2008-00001
Event key
0
Event type
3
Date of event
2008-04-10
Date received
2008-07-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
2920 N. ARLINGTON HEIGHTS ROAD ARLINGTON HEIGHTS IL 60006 US
Phone
847-847-8473
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SEDECALDIAGNOSTIC X-RAY SYSTEMSEDECAL S.A.IZOX-PLUS LPY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-07-100

Event Narratives#

D

Patient 1

THE DEVICE IS A STATIONARY DIAGNOSTIC X-RAY SYSTEM WITH A MOTORIZED "C-ARM" TUBEHEAD/BUCKY ASSEMBLY. THE TECHNOLOGIST WAS PREPARING TO DO FOOT STUDY. THE TUBE WAS ROTATED TO POINT DOWN TO THE FLOOR. THE FIRST EXPOSURE WAS TAKEN. PREPARING TO MAKE A STANDING FOOT EXPOSURE, THE C-ARM WAS THEN ANGLED TO LESS THAN 90 DEGREES WITH THE TUBE POINTING TO THE FLOOR. THE TECHNOLOGIST ADJUSTED THE TUBE (SID) REDUCING THE DISTANCE BETWEEN THE TUBE AND THE BUCKY TO IMPROVE THE ALIGNMENT TO THE DIGITAL SENSOR. WHILE THE TUBE WAS MOVING, AN ERROR WAS DISPLAYED ON THE LED INDICATOR. THE TECH WAS NOT SURE OF THE ERROR CODE; MAYBE -31. AT THIS POINT, THE SYSTEM FROZE. THE TECH WAS UNABLE TO MAKE THE SYSTEM RESPOND. SHE REBOOTED THE SYSTEM. DURING THE BOOTING PROCESS THE LED DISPLAY FLASHED AN ERROR CODE WITH A LINE THROUGH IT. THE LCD DISPLAY HAD LINES THROUGH THE DISPLAY AND WAS ALSO FLASHING. TECH THEN TRIED TO MOVE THE CARRIAGE DOWN BY DEPRESSING THE DOWN BUTTON AT THE CONTROL PANEL BUT IT DID NOT RESPOND. SHE RELEASED THE DOWN BUTTON AND SUDDENLY THE CARRIAGE BEGAN TO MOVE DOWN SLOWLY. THE CARRIAGE CONTINUED TO MOVE DOWN TO THE FLOOR. THE STEEL CABLE BEGAN TO UNWIND AFTER THE CARRIAGE CAME INTO CONTACT WITH THE FLOOR. AFTER HEARING A NOISE FROM THE REAR OF THE UNIT THE TECH HIT THE EMERGENCY STOP BUTTON AND THE MOTION STOPPED.

N

Patient 1

THE DIAGNOSTIC X-RAY SYSTEM EXPERIENCED UNCOMMANDED MOVEMENT OF THE TUBE-HEAD/BUCKY ASSEMBLY (AKA "C-ARM"). AN UPGRADE TO THE CONTROL LOGIC HAS BEEN MADE TO SYSTEMS MANUFACTURED DURING AND AFTER APRIL 2007. THIS UPGRADE PREVENTS UNCOMMANDED SYSTEM MOVEMENT. THE SYSTEM THAT MALFUNCTIONED HAD NOT RECEIVED THIS UPGRADE. THE SYSTEM WAS REPAIRED AND THE UPGRADE APPLIED. SEDECAL HAD PREPARED A LIST OF ALL SYSTEMS REQUIRING THE UPGRADE AND IS IN THE PROCESS OF APPLYING THE UPGRADE TO ALL AFFECTED SYSTEMS IN THE FIELD.