BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 13579809 · Received February 22, 2022

    Report

    Report Number
    1119779-2022-00277
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    January 26, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    00382904441500
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: ON SYNAPSYS (MATERIAL 444150 / SN (B)(6)) HOMESCREEN, THE READY FOR READING SCHEDULE LOADS VERY SLOWLY. THERE, THE SCHEDULE / COLUMNS LOAD MUCH QUICKER INITIALLY, HOWEVER AN AUTOMATIC UPDATE OF THAT DATA ("LOADING..." IS DISPLAYED) TAKES VERY LONG. THE CURRENT SOFTWARE VERSION IS 3.71. RECOMMENDATION IS TO UPGRADE TO A NEW VERSION OF SYNAPSYS. UNABLE TO DETERMINE THE ROOT CAUSE OF THIS SLOWNESS. THIS IS NOT A CONFIRMED COMPLAINT OF A BD PRODUCT. PER BALTRM-SYNAPSYS-APH REVISION 25, THE FAILURE ASSOCIATED TO THIS COMPLAINT IS A USER ANNOYANCE WHICH IS A SEVERITY OF S1; REFERENCE ID 59. COMPLAINTS FOR APPLICATION WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF JANUARY. NO TRENDS INDICATED. DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED FOR STANDALONE SOFTWARE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYNAPSYS¿ THE "READY FOR READING" SCREEN IT TOO SLOW. THERE WAS NO REPORT OF ERRONEOUS RESULTS OR ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "ON THE SYNAPSYS HOME SCREEN, THE READY FOR READING SCHEDULE LOADS VERY SLOWLY. A TILE CONFIGURED ON SYNAPSYS DASHBOARD KEEPS LOADING AND NOT SHOWING DATA. RE-CREATED THE SAME TILE ON SYNAPSYS ADMIN ACCOUNT AND NOTICED THAT IT IS INITIALLY SHOWING DATA BUT AS SOON AS THE PAGE REFRESH A LOADING SCREEN IS SHOWN."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYNAPSYS¿ THE "READY FOR READING" SCREEN IT TOO SLOW. THERE WAS NO REPORT OF ERRONEOUS RESULTS OR ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "ON THE SYNAPSYS HOME SCREEN, THE READY FOR READING SCHEDULE LOADS VERY SLOWLY. A TILE CONFIGURED ON SYNAPSYS DASHBOARD KEEPS LOADING AND NOT SHOWING DATA . RE-CREATED THE SAME TILE ON SYNAPSYS ADMIN ACCOUNT AND NOTICED THAT IT IS INITIALLY SHOWING DATA BUT AS SOON AS THE PAGE REFRESH A LOADING SCREEN IS SHOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161472 BD SYNAPSYS¿ NA JQP BECTON, DICKINSON & CO. (SPARKS) UNKNOWN 00382904441500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown