BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 20674054 · Received November 13, 2024

    Report

    Report Number
    9610816-2024-00809
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 21, 2024
    Report Date
    December 5, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS REPORTED UNDER INCORRECT REGISTRATION NUMBER, PLEASE REFER TO 1218950-2024-000860 FOR FURTHER INFORMATION REGARDING THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    (B)(6). PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SPEAKER FAILURE. IT IS UNKNOWN IF THE DEVICE WAS ABLE TO PRODUCE SOUND. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313514 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown