BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERICORD RECORD & VERIFY SOFTWARE V.2.2.1

    MDR report key: 32160 · Received April 22, 1996

    Report

    Report Number
    MW1008927
    Event Type
    Malfunction
    Date Received
    April 22, 1996
    Date of Event
    April 10, 1996
    Report Date
    April 16, 1996
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT INVOLVED THREE EVENTS: 1. THE FAILURE OF THE SYSTEM TO PROPERLY RECORD A TREATED FIELD ON A RECORD CARD. 2. THE COPYING OF THAT TREATMENT INFO ONTO THE CARD OF ANOTHER PT. 3. THE SUBSEQUENT NON-PRINTING OF 2 RX'S ON THE CARD OF THE SECOND PT. 1. PT 1, A 4 FIELD ABDOMEN, HAD RECEIVED 11 TREATMENTS, ALL PROPERLY RECORDED BY THE SYSTEM. ON 4/9/96 ONLY FIELDS 2,3 & 4 WERE RECORDED ON THE CARD. FIELD 1 WAS MISSING. THE ACCUMULATED DOSE ON THE CARD WAS CORRECT AS WAS THE INFO IN THE PT'S ELECTRONIC FILE AND THE DAILY RECORD. THIS WAS BROUGHT TO THE ATTENTION OF THE MFR'S ENGINEER. NO ERROR CODES WERE GENERATED, HOWEVER, AND NO OTHER PROBLEMS PRESENTED THEMSELVES. 2. ON 4/10/96, ALL 4 FIELDS OF PT 1'S 4/9/96 FIELD 1 WAS RECORDED ON PT 2'S CARD. PT 2'S ACCUMULATED ELECTRONIC FILE DOSE AND DAILY RECORD DATA WERE CORRECT. A TEST CASE WAS RUN TO CHECK THE PRINT PROCESS AND WAS FOUND TO BE OK. THE ENGINEER CHECKED THE HARD DISK AND FOUND NO ERRORS ON THE DRIVE. NO ERRORS PRESENTED FOR ANY OF THE OTHER PTS. THE INCIDENT WAS REPORTED TO MFR'S TECHNICAL ASSISTANCE PEOPLE WHO COULD OFFER NO IMMEDIATE EXPLANATION. 3. ON 4/11/96, PT 1'S CARD CONTINUED TO PRINT CORRECTLY FOLLOWING TREATMENT. AFTER TREATING PT 2, HOWEVER, THE OPERATOR'S SCREEN PROMPTED: BLANK SHEET? INS NEW SHEET PT 2 NAME 2-1.2.1. A NEW CARD WAS PRINTED. ONLY PT 2'S 3RD ELECTRON TREATMENT WAS RECORDED. TREATMENTS 1 AND 2 WERE NOT. THE ACCUMULATED DOSE TOTAL WAS CORRECT. THE ENGINEER ATTEMPTED TO FOLLOW-UP WITH THE MFR'S APPLICATIONS SPECIALIST. 4. ON 4/12/96, TREATMENT #4 WAS CORRECTLY PRINTED FOR PT 2. NO REF WAS MADE BY THE SYSTEM FOR PRINTING TREATMENTS 1 & 2. FOLLOW-UP CONTINUED WITH APPLICATIONS. 5. ON 4/15/96, APPLICATIONS CONFIRMED THAT NO IMMEDIATE EXPLANATION COULD BE GIVEN FOR THE EVENTS DESCRIBED ABOVE. 6. ON 4/16/96, MFR WAS NOTIFIED OF FILING OF FDA REPORT. THE FIELD ENGINEER WILL FILE A FIELD SVC PROBLEM REPORT WITH MFR. CORRECTIVE ACTIONS: PENDING INSTRUCTIONS FROM THE MFR, TECHNOLOGISTS WERE INSTRUCTED TO CAREFULLY MONITOR PRINTOUTS AND REPORT ANY ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERICORD RECORD & VERIFY SOFTWARE V.2.2.1 LINEAR ACCELERATOR IYE PHILIPS MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO