BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 12199516 · Received July 20, 2021

    Report

    Report Number
    1218950-2021-10729
    Event Type
    Death
    Date Received
    July 20, 2021
    Date of Event
    July 3, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE CLINICAL SUPPORT SPECIALIST (RCS) TALKED TO THE CUSTOMER TO TROUBLESHOOT THE EVENT. THE RCS PULLED THE AUDIT LOGS FROM THE EVENT AND FOUND A LOT OF TECHNICAL ALARMS THAT WERE SOUNDING BUT WERE NOT ACKNOWLEDGED. THE RCS WAS ABLE TO DETERMINE THAT THERE WAS NO MALFUNCTION OF THE PHILIPS DEVICE. THE CUSTOMER STILL HAD MANY QUESTIONS REGARDING HOW TECHNICAL ALARMS WORK AND WHETHER OR NOT SOUND WOULD BE PLAYED FOR THE TECHNICAL ALARMS. THE RCS TALKED TO THE CUSTOMER OVER THE PHONE AND ANSWERED ALL OF THEIR QUESTIONS. THE CUSTOMER WAS THEN PROVIDED WITH A LIST OF POSSIBLE CAUSES FOR THE TECHNICAL ALARMS TO AVOID ANY ISSUES IN THE FUTURE. THEIR WAS NO MALFUNCTION OF THE PHILIPS DEVICE. THE RCS REVIEWED THE AUDIT LOG WITH THE CUSTOMER AND FOUND THAT THE SYSTEM WAS ALARMING AS EXPECTED. THE RCS ANSWERED ALL OF THE CUSTOMERS QUESTIONS TO ENSURE THAT THEY UNDERSTAND HOW TO HANDLE AND RECOGNIZE TECHNICAL ALARMS MOVING FORWARD TO AVOID ANY FURTHER COMPLICATIONS. THE DEVICE REMAINS ON SITE AND IN USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ON (B)(6) 2021 A PATIENT EXPIRED AND THEY WANTED TO PULL THE AUDIT LOG DATA. THE DEVICE WAS IN USE, THE PATIENT DIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2021 A PATIENT EXPIRED AND THEY WANTED TO PULL THE AUDIT LOG DATA. THE DEVICE WAS IN USE, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093415 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death