BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 18320784 · Received December 13, 2023

    Report

    Report Number
    1218950-2023-00930
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 30, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED), WHO CARRIED OUT TESTS WHICH SHOWED THE PROPER FUNCTIONING OF THE ALARMS. FURTHER INFORMATION WAS REQUESTED REGARDING THE TYPE OF ALARM, HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. PER THE RSE, THE BIOMED REFUSED TO PROVIDE PIC IX LOGS. THE BIOMED DID INDICATE THAT THE PIC IX IS OPERATIONAL, AND THAT PREVENTIVE MAINTENANCE WAS PLANNED FOR THE BEGINNING OF DECEMBER. NO FAILURE WAS IDENTIFIED, HOWEVER, PHILIPS COULD NOT RULE OUT AN ISSUE AT THE TIME OF THE REPORTED EVENT. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. REPORTING ADDRESS STATE: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON A PHILIPS PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT THERE WAS AN ALARM REPORTING PROBLEM; THE TYPE OF ALARM PROBLEM WAS NOT SPECIFIED. IT WAS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768877 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown