FDA.reportPublic FDA data

MAUDE MDR 1470095

MDR report key
1470095
Report number
9616853-2009-00001
Event key
0
Event type
3
Date of event
2009-07-02
Date received
2009-07-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
NICOLE WHERRY
Address
2340 PEGASUS WAY NE SUIE 151 CALGARY, ALBERTA T2E 8 CA
Phone
866-866-8669
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1X3C 2200 WITH MAGELLAN 3.4 SOFTWARE INSATLLEDDIGITAL X-RAY IMAGING SYSTEMIMAGING DYNAMICS COMPANY (IDC)KPRX3C 2200 (M3. 4)N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-07-300

Event Narratives#

D

Patient 1

AN IMAGING DYNAMICS COMPANY (IDC) X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM WAS IN USE AT (B)(6). AT APPROX 9:00 PM AN IMAGE OF THE PT TAKEN BY THE RADIOLOGY TECHNICIAN APPEARED ON THE SYSTEM PREVIEW SCREEN, BUT SUBSEQUENTLY DID NOT APPEAR IN THE STUDY ON THE IDC UNIT. THE SUBJECT REQUIRED AN ADDITIONAL EXPOSURE TO COMPENSATE FOR THE MISSING IMAGE. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THE COMPUTER WAS NOT CONFIGURED AS REQUIRED BY ICD, AND A LACK OF ADEQUATE AVAILABLE COMPUTER MEMORY CAUSED A LONG IMAGE PROCESSING TIME TO OCCUR. DURING THE INITIAL IMAGE PROCESSING, THE RADIOLOGY TECHNICIAN ATTEMPTED TO TAKE ANOTHER EXPOSURE CAUSING THE INITIAL IMAGE TO BE LOST. THERE WAS NO INJURY TO ANY HEALTH PROFESSIONAL. THERE WAS NO ACCIDENTAL RADIATION EXPOSURE.