BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0

    MDR report key: 10734329 · Received October 26, 2020

    Report

    Report Number
    1218950-2020-06416
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Report Date
    October 12, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXJ
    UDI-DI
    00884838075153
    PMA / PMN Number
    K100272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE CUSTOMER ACKNOWLEDGES THIS WAS A WORKFLOW ERROR AND REQUESTING THAT A CHANGE BE MADE TO THE ICCA SOFTWARE APPLICATION AS A PREVENTATIVE MEASURE. THE CUSTOMER WAS PROVIDED WITH INFORMATION. THE EVENT IS CONSIDERED USER ERROR AND NOT A MALFUNCTION OF THE PHILIPS PRODUCT. DETAILS OF THIS INCIDENT HAVE BEEN SENT TO THE PHILIPS PRODUCT TEAM FOR REVIEW SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DRUG ERROR TO MRC (#0116281159) . A PATIENT RECEIVED A DOUBLE DOSE OF THE ANTIVIRAL DRUG¿AMIKACIN¿ DUE TO A WORKFLOW ERROR. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203180 INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 CLINICAL INFORMATION MANAGEMENT SYSTEM DXJ PHILIPS MEDICAL SYSTEMS 866148 00884838075153

    Patients

    Seq Age Sex Outcome Treatment
    1 Other