FDA.reportPublic FDA data

MAUDE MDR 856291

MDR report key
856291
Report number
MW5001955
Event key
0
Event type
3
Date of event
2007-05-22
Date received
2007-05-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SIEMENSANTARES ULTRASOUNDSIEMENSBZQANTARESNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-05-2201. S

Event Narratives#

D

Patient 1

SIEMENS MEDICAL SYSTEMS ANTARES ULTRASOUND SYSTEM HAS A KNOW SOFTWARE BUG THAT SIEMENS HAS BEEN MADE AWARE OF YET HAS TAKEN NO DEFINITIVE STEPS TO CORRECT. THE ANTARES SYSTEM IS DESIGNED TO PURGE PT STUDY INFO WITHIN 24 HOURS OF THE END OF THE STUDY MAKING THE INFO UNAVAILABLE FOR OTHERS TO VIEW AND CLEARING MEMORY WITHIN THE SYSTEM. INSTEAD, THE STUDIES ARE SAVED CONTINUOUSLY UNTIL THE OPERATORS BECOME CONFUSED AS TO THE CORRECT STUDY PLACING PATIENTS AT RISK. SIEMENS ACKNOWLEDGES THE ISSUE AND CHARGES CUSTOMERS TO CORRECT THE ISSUE EACH TIME IT OCCURS, BUT SAID THEY CANNOT FIX THE ISSUE AT THIS TIME.