BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 15904684 · Received December 2, 2022

    Report

    Report Number
    1218950-2022-01037
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    October 28, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K153702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SERIAL NUMBER (SN) TO (B)(6) PER CONFIRMATION FROM GOOD FAITH EFFORT (GFE) THAT THIS IS THE CORRECT SN. SERIAL NUMBER ((B)(6)) MANUFACTURE DATE WAS CONFIRMED AND UPDATED.

    Additional Manufacturer Narrative · 0

    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. (B)(6).

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER (RSE) AND A FIELD SERVICE ENGINEER (FSE) PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE CENTRAL SCREENS WERE ¿FROZEN¿. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS DUE TO SOFTWARE DEFECTS AND ENHANCEMENTS PER FCO86201964. THE SYSTEM WAS CONFIRMED "FROZEN" AS NO ALARMS AND WAVES WERE SHOWING AT THE CENTRAL STATION. THE REMEDY TO FCO86201964 WAS TO INSTALL PIC IX C.03.08 TO THE SYSTEM. THE REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CENTRAL SCREENS ARE "FROZEN", ALARMS FROM MONITORS COULD NOT BE HEARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385550 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown