BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 22417077 · Received July 7, 2025

    Report

    Report Number
    9610816-2025-000567
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 31, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838122772
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER. ONSITE SERVICE WAS SCHEDULED BUT WAS CANCELLED BY THE CUSTOMER SO THE ISSUE IS NOT CONFIRMED. GOOD FAITH EFFORT (GFE) ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. HOWEVER, THE CUSTOMER DID NOT RESPOND. THE CAUSE OF THE ISSUE AND RESOLUTION ARE UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    H6 EVALUATION RESULTS CHANGED FROM FDA C CODE C92084 [NO FINDINGS AVAILABLE] TO C92083 [NO DEVICE PROBLEM FOUND]. A GOOD FAITH EFFORT (GFE) RESPONSE WAS RECEIVED FROM THE BIOMEDICAL ENGINEER INDICATING THAT THE ALARM WAS NOT DELAYED AND THE ISSUE COULD NOT BE DUPLICATED. THE BIOMED INDICATED THAT THE ALARM WAS TESTED WITH A FLUKE PATIENT SIMULATOR. BOTH LOW AND HIGH PRESSURE WERE SIMULATED, AND IN BOTH CASE THE YELLOW ALARM BANNER WITH AUDIBLE LOW SOUND ALARM WAS DISPLAYED AT THE CENTRAL MONITORING UNIT. THE SYSTEM WAS FOUND TO BE WORKING PROPERLY, AND ALARMING AS SHOULD BE FOR LOW AND HIGH PRESSURE. THE ISSUE WAS NOT CONFIRMED AND THE DEVICE REMAINS IN THE USE. 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 (PIC IX) INDICATING EXTREMELY LONG DELAYS WITH ALARMS AND ALERTS. THE DEVICE WAS IN CLINICAL 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
    7571 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX 4.3.3.0 00884838122772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown