BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 20300225 · Received September 25, 2024

    Report

    Report Number
    1218950-2024-00684
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    September 17, 2024
    Report Date
    September 25, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INVOLVEMENT WAS REPORTED. INTERNAL COMMUNICATIONS CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT. THE CUSTOMER CONFIRMED THAT THE REPORTED ISSUE WAS RESOLVED IN HOUSE AND NO FURTHER ASSISTANCE WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT INFORMATION CENTER (PIC) IX IS COMPLETELY DOWN. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198789 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown