BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 13994140 · Received April 4, 2022

    Report

    Report Number
    1218950-2022-00295
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 8, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHONE NUMBER (B)(6). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INTEGRATION OF ARCOMED INFUSION PUMP DEVICE VIA INTELLIBRIDGE DRIVER BD515 LAN DOES NOT GENERATE A TECHNICAL ALARM WHEN THE ARCOMED DEVICE GETS DISCONNECTED FROM THE PATIENT INFORMATION CENTER IX (PIC IX) C.03. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INTEGRATION OF ARCOMED INFUSION PUMP DEVICE VIA INTELLIBRIDGE DRIVER BD515 LAN DOES NOT GENERATE A TECHNICAL ALARM WHEN THE ARCOMED DEVICE GETS DISCONNECTED FROM THE PATIENT INFORMATION CENTER IX (PIC IX) C.03. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042918 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown