FDA Adverse Event Summary report: N

VERICORD RECORD, VERIFY SOFTWARE

MDR report key: 33678 · Received June 21, 1996

Report

Report Number
MW1009351
Date Received
June 21, 1996
Date of Event
June 7, 1996
Report Date
June 12, 1996
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Product Code
IYE
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PHYSICIST

Narratives

Description of Event or Problem · 1

ON TWO SEPARATE OCCASIONS INVOLVING TWO DIFFERENT PTS, THE DEVICE TERMINATED TREATMENT PRIOR TO DELIVERING ANY RADIATION. IN BOTH CASES, A "FINISH BEAM" FILE WAS CREATED IN WHICH A NUMBER OF BEAM PARAMETERS (IE FIELD SIZE, GANTRY ANGLE, ETC) WERE ALTERED FROM THOSE ORIGINALLY PRESCRIBED. THE SYSTEM THEN PROMPTED THE OPERATOR TO "FINISH BEAM?". IF THE OPERATOR HAD ANSWERED "YES" THE SYSTEM WOULD HAVE PERMITTED TREATMENT WITH THE WRONG BEAM VALUES. IN THE TWO CASES CITED, THE ANOMALIES WERE IDENTIFIED AND THE OPERATOR WAS INSTRUCTED TO DELETE THE CORRUPTED "FINISH BEAM" PRESCRIPTION AND RESET THE SYSTEM. BOTH PTS WERE THEN CORRECTLY TREATED WITHOUT INCIDENT. IT SHOULD BE NOTED THAT UNTIL THE "FINISH BEAM" FILE IS DELETED, THE SYSTEM WILL PROMPT THE OPERATOR TO TREAT THE PT ON SUBSEQUENT DAYS WITH THE ALTERED BEAM DATA. THE INCIDENTS WERE REPORTED TO THE MFR IN ENGLAND WHO COULD NOT EXPLAIN THE REASON FOR THE PREMATURE TERMINATION OF THE BEAM. THEY DID STATE THAT THIS WAS "A KNOWN SOFTWARE PROBLEM THAT WILL BE FIXED IN A FUTURE SOFTWARE RELEASE SOMETIME IN 1997." OPERATORS WERE CAUTIONED ABOUT THE ABOVE CONDITION AND THE NECESSITY OF CONSTANT VIGILANCE DURING TREATMENT DELIVERY. THEY WERE ALSO INSTRUCTED ABOUT THE IMPORTANCE OF IMMEDIATELY DELETING THE CORRUPT "FINISH BEAM" FILES. MFR HAS REQUESTED THAT A BACKUP TAPE BE SENT TO ENGLAND IN THE EVENT THAT THE PROBLEM SHOULD OCCUR AGAIN. THE MFR, HOWEVER, HAS YET TO ISSUE A WARNING NOTICE TO THE END USERS REGARDING THIS SITUATION, DESPITE THE FACT THAT THIS IS A RECOGNIZED DEFICIENCY FOR WHICH NO SOLUTION IS IMMEDIATELY FORTHCOMING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VERICORD RECORD, VERIFY SOFTWARE LINEAR ACCELERATOR IYE PHILIPS MEDICAL SYSTEMS, INC.

Patients

Seq Age Sex Outcome Treatment
1 NO INFO