BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 11615519 · Received April 5, 2021

    Report

    Report Number
    1218950-2021-10287
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    March 9, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO TROUBLESHOOT THE ISSUE. THE FSE PULLED THE CLINICAL AUDIT LOGS FOR A PHILIPS CLINICAL PRODUCT SPECIALIST (CPS) TO REVIEW. THE CPS REVIEWED THE AUDIT LOGS AND CONFIRMED THAT THERE WAS AN EXTENDED PERIOD OF TIME WERE THE PATIENT WAS NOT BEING MONITORED. THE LOGS INDICATE THAT A LEADS OFF EVENT OCCURRED AT 23:45. THE CUSTOMERS SYSTEM WAS CONFIGURED TO SHUT OFF THE MONITORING DEVICE AFTER 10 MINUTES OF "ECG LEAD OFF". ONCE THE MONITORING DEVICE WENT OFFLINE A MESSAGE WAS LATCHED WITHIN THE SECTOR STATING THAT THE TRANSMITTER WAS OFF. ONCE THE LEADS WERE REATTACHED TO THE PATIENT THE SYSTEM ALARMED FOR AN ASYSTOLE EVENT. THE CPS CONFIRMED THAT THE SYSTEM WAS OPERATING AS DESIGNED PER THE CUSTOMERS CONFIGURATIONS. THERE WAS NO MALFUNCTION OF THE PHILIPS DEVICE. THE CPS REVIEWED THE LOGS AND DETERMINED THAT THE SYSTEM WAS ALARMING AS CONFIGURED. A LEADS OFF EVENT TURNED INTO A "TRANSMITTER OFF" MESSAGE WHICH WAS LATCHED WITHIN THE SECTOR OF THE AFFECTED PATIENT DURING THE ENTIRE EVENT. THE CPS RECOMMENDS THAT THE CUSTOMER ADJUST THEIR ALARM SETTINGS IF THEY WISH TO SEE THE LEADS OFF MESSAGE LATCHED WITHIN THE SECTOR INSTEAD. THE CUSTOMER WAS PROVIDED A LETTER EXPLAINING THE SITUATION WHICH RESOLVED THE ISSUE. THE DEVICE REMAINS ON SITE AND IN USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ONE PATIENT WAS NOT BEING CENTRALLY MONITORED AND REQUIRED A HIGHER LEVEL OF CARE AS A RESULT. A PATIENT WAS NOT BEING CENTRALLY MONITORED AND REQUIRED ADDITIONAL MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE PATIENT WAS NOT BEING CENTRALLY MONITORED AND REQUIRED A HIGHER LEVEL OF CARE AS A RESULT. A PATIENT WAS NOT BEING CENTRALLY MONITORED AND REQUIRED ADDITIONAL MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512241 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization