BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21988664 · Received May 8, 2025

    Report

    Report Number
    1218950-2025-000291
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 14, 2025
    Report Date
    July 15, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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.

    Additional Manufacturer Narrative · 0

    A REMOTE SERVICE ENGINEER (RES) LOGGED INTO THE SYSTEM FOR TROUBLE SHOOTING AND THE CUSTOMER NOTED THAT THE SYSTEM WAS NOT ALARMING AS FAST AS OTHER MONITORS IN THE UNIT. THE LENGTH OF THE DELAY WAS NOT RECORDED. PHILIPS REMOTE CLINICAL SUPPORT (RCS) CHECKED THE CONFIGURATION AND NOTED DELAYS OF 10 SECONDS AND 20 SECONDS FOR DESAT HIGH/LOW ALARMS. THE RCS EXPLAINED THAT WITH THESE CONFIGURATIONS, IT COULD TAKE UP TO 30 SECONDS BEFORE A RED LEVEL ALARM WOULD ACTIVATE. THE ALARM LOGS WERE REVIEWED BY THE RCS AND NOTED MULTIPLE YELLOW LEVEL ALARMS AND SOME RED LEVEL ALARM. THE RCS AND RSE DID NOT RETAIN THE LOGS AND CONFIGURATION FILES FOR THE RECORD, NOR DID THEY KNOW THE PRECISE TIME THE ISSUES OCCURRED IN ORDER TO CONFIRM IF THE DELAY WAS OCCURRING OUTSIDE OF THE ALLOWABLE DELAY OF UP TO 30 SECONDS. THE RCS RECOMMENDED THE CUSTOMER CHECK THE SYSTEM TO VERIFY IF THE DELAYS ARE LONGER THAN WHAT IS CURRENTLY CONFIGURED AND ALSO RECOMMENDED ADJUSTING CONFIGURATION AS NEEDED TO REDUCE THE DELAY. GOOD FAITH EFFORT WAS MADE TO FOLLOW UP AND VERIFY THE MISSING INFORMATION AND THE FINAL OUTCOME OF THE DEVICE; HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE ENGINEER PROVIDED THEIR ANALYSIS FINDINGS HOWEVER WE ARE UNABLE TO CONFIRM THE FINAL DISPOSITION OF THE DEVICE BECAUSE THE CUSTOMER DID NOT RESPOND TO REQUESTS FOR ADDITIONAL INFORMATION. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE DSAT ALARM FOR THE PATIENT IS DELAYED; IT WAS NOT ALARMING AS FAST AS OTHER MONITORS. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021658 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male