BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE CLINICAL INFORMATION PORTFOLIO (ICIP)

    MDR report key: 1921986 · Received December 8, 2010

    Report

    Report Number
    1218950-2010-02366
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Report Date
    November 12, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    DXJ
    PMA / PMN Number
    K992636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THERE WAS NO EXPECTED RED FLAG IN ICIP FOLLOWING A SUSPENSION OF AN IV DRIP. NO PATIENT HARM WAS REPORTED. FROM THE LIMITED AVAILABLE INFO, PHILIPS CANNOT DETERMINE IF THERE WAS ANY SOFTWARE MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO EXPECTED RED FLAG FOLLOWING A SUSPENSION OF AN IV DRIP. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE CLINICAL INFORMATION PORTFOLIO (ICIP) DXJ PHILIPS HEALTHCARE 865047

    Patients

    Seq Age Sex Outcome Treatment
    1