BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 18334394 · Received December 15, 2023

    Report

    Report Number
    1218950-2023-00938
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    December 4, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE STAFF COULD NOT HEAR ALARMS AT THE CENTRAL STATION BUT COULD HEAR THE ALARMS FROM THE BEDSIDE. IT WAS DETERMINED THAT THE PIIC IX WAS NOT MAKING ANY SOUNDS WHEN IT WAS POWERING ON OR WHEN IT WAS ALARMING. THE STAFF WAS ABLE TO SEE VISUALLY THE LIGHT OUTSIDE THE ROOM AND ON THE SURVEILLANCE. THE REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER AND ADVISED TO REBOOT THE SURVEILLANCE, AND THIS DID NOT CORRECT THE ISSUE. THE RSE HAD THE CUSTOMER CHECK THE SPEAKER AND ITS CONNECTION, BUT IT DID NOT CORRECT ISSUE. THE RSE ASKED THE CUSTOMER TO OBTAIN ANOTHER SPEAKER AND TO THEN SWAP IT OUT AND SEE IF THE ISSUE IS WITH THE ORIGINAL SPEAKER, BUT THE CUSTOMER DID NOT HAVE A SPARE SPEAKER. THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND REPLACED THE SPEAKER, AND THE SYSTEM WAS WORKING AS INTENDED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE SPEAKER. THE REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS OPERATIONAL AFTER REPLACING THE SPEAKER. THE SERIAL NUMBER WAS CORRECTED TO REFLECT THE SOFTWARE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PIIC IX IS NOT MAKING ANY SOUNDS WHEN IT IS POWERING ON IT WILL NOT MAKE SOUND AND WHEN IT IS ALARMING THEY CAN'T HEAR IT EITHER. THEY CAN SEE VISUALLY THE LIGHT OUTSIDE THE ROOM AND ON THE SURVEILLANCE; HOWEVER, THE PIIC IX IS NOT MAKING ANY SOUNDS. THE CUSTOMER REBOOT THE SURVEILLANCE AND THIS DID NOT CORRECT ISSUE. THEY ALSO CHECKED THE SPEAKER CONNECTION AND THIS DID NOT CORRECT ISSUE. THEY WERE ASKED TO OBTAIN ANOTHER SPEAKER AND TO THEN SWAP IT OUT AND SEE IF THE ISSUE IS WITH THE ORIGINAL SPEAKER, BUT THEY DID NOT HAVE A SPARE. 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
    1041162 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown