BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE CLINICAL INFORMATION PORTFOLIO (ICIP)

    MDR report key: 1870465 · Received October 6, 2010

    Report

    Report Number
    1218950-2010-01830
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Report Date
    September 15, 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 THE ICIP DISPLAYED AN ELECTROLYTE VALUE THAT WAS NOT ENTERED BY A USER. NO PT HARM WAS REPORTED. THE LIMITED AVAILABLE INFO IS NOT SUFFICIENT TO SUPPORT THAT THIS POSES A HEALTH RISK. 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 THE ICIP DISPLAYED AN ELECTROLYTE VALUE THAT WAS NOT ENTERED BY A USER. NO PT 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