FDA Adverse Event Other Summary report: N

PHILLIPS MEDICAL SYSTEM/ADAC WORKLIST

MDR report key: 748871 · Received October 18, 2005

Report

Report Number
MW1036951
Event Type
Other
Date Received
October 18, 2005
Date of Event
October 7, 2005
Report Date
October 18, 2005
Manufacturer
PHILLIPS MEDICAL SYSTEM
Product Code
LNX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

HAD ADAC/PHILLIPS WORKLIST SOFTWARE INSTALLED ON A CARDIO MD/BLADE SYSTEM. BY TIME PHILLIPS MEDICAL SYSTEM FINALLY HAD THE SOFTWARE "WORKING" -TOOK ABOUT 3 MONTHS- FOR TRANSFER INTO A PAC'S SYSTEM -DEPTH- HOSP DISCOVERED THAT THE SOFTWARE WAS SPLITTING OUT INDIVIDUALS IMAGES IN A PATIENTS' DATA FILE AND FILING IN THE PACE SYSTEM UNDER OTHER PATIENTS' ID NUMBERS AND NAMES. HOSP IMMEDIATELY TERMINATED USE OF THIS SOFTWARE AND ALL CORRUPTED FILES WERE DELETED AND ALL THE AFFECTED PATIENTS' STUDIES WERE REINTERPRETED BY THE RADIOLOGIST. THE SOFTWARE WAS SUPPOSED TO BE REMOVED FROM HOSP SYSTEM BUT HAS NOT BEEN AT THIS TIME. -THIS WILL NOT AFFECT FURTHER STUDIES AS THE ONLY WAY HOSP COULD EVER GET THE SOFTWARE TO WORK WAS TO "MANUALLY" INITIATE IT WITH EACH INDIVIDUAL PATIENT, THE AUTOMATIC TRANSFER NEVER WORKED. THE ISSUE WAS BROUGHT UP WITH THE PHILLIPS ENGINEER WHO PASSED IT ALONG TO HIS SUPERIORS AND ALSO WAS POINTED OUT TO A REGIONAL PRODUCT/SALES MANAGER. NO RESPONSE FROM THE PRODUCT MANAGER AND THE ONLY RESPONSE FROM THE ENGINEER WAS THAT THE CORPORATE HEADQUARTERS FINALLY ADMITTED TO HIM THAT THE SOFTWARE WAS NEVER DESIGNED FOR THE CARDIOMD/BLADE SYSTEM BUT ONLY FOR THE PEGASS/ATLAS SYSTEM AND TO PULL IT ASAP WHEN THEY FOUND OUT HOSP DISCOVERED THE PATIENT DATA CORRUPTION. HOSP NEVER RECEIVED THIS INFO DIRECTLY OR OFFICIALLY. RPTR'S ONLY CONCERN IS THAT EVEN THOUGH HOSP "DISCOVERED THIS ISSUE" HOW MANY OTHER FACILITIES ARE USING THIS WITHOUT KNOWLEDGE OF THE PROBLEM. SOFTWARE NOT USED CURRENTLY, BUT STILL ON COMPUTER SYSTEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PHILLIPS MEDICAL SYSTEM/ADAC WORKLIST SOFTWARE LNX PHILLIPS MEDICAL SYSTEM WORKLIST SOFTWARE NA

Patients

Seq Age Sex Outcome Treatment
1 * Other