BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX HARDWARE

    MDR report key: 16137058 · Received January 11, 2023

    Report

    Report Number
    1218950-2023-00018
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 12, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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.

    Description of Event or Problem · 0

    STATEMENT OF THE REPORTED PROBLEM: THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE ENGINEER (RSE) PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE PIC IX C ST EFP INDICATING THAT AFTER A SOFTWARE UPDATE HAD BEEN DONE ON THE PIC THE POP UP ALARM TONE THAT HAD BEEN CONFIGURED TO GENERATE AT THE PIC WAS NO LONGER CONFIGURED. THIS TONE WAS CONFIGURED TO SOUND WHEN A POP UP WINDOW WAS GENERATED AT A PATIENT MONITOR THIS WAS NOTICED AND REPORTED BY THE USERS. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED ISSUE. THERE WAS NO REPORT OF AN ADVERSE EVENT. CONFIRMATION: BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO HAVE OCCURRED DURING THE PIC SOFTWARE UPDATE. IT IS NOT KNOWN WHO PERFORMED THE UPDATES OR IF THE PREVIOUS SETTINGS WERE CHECKED TO BE STILL IN PLACE AS EXPECTED. THE REPORTED PROBLEM WAS CONFIRMED. FURTHER ACTION DECISION: BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, THE PHILIPS RSE WORKING WITH THE CUSTOMER REMOTELY RECONFIGURED THE PIC IX TO GENERATE THE POP UP ALARM TONE AS EXPECTED. CLOSURE & PRODUCT DISPOSITION: SERVICEABLE ¿ PRODUCT BACK IN SERVICE ¿ NO FURTHER ACTION REQUIRED: THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. THE CUSTOMER WAS REMOTELY ASSISTED IN RECONFIGURING THE PIC IX TO THE SAME SETTINGS CONFIGURED BEFORE THE SOFTWARE UPDATE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR ALARM AUDIO SETTINGS NEEDED TO BE ADJUSTED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908848 PIC IX HARDWARE PIC IX HARDWARE MHX PHILIPS MEDICAL SYSTEMS 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown