BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 12025805 · Received June 18, 2021

    Report

    Report Number
    1218950-2021-10664
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    June 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
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED). THERE HAD BEEN AN INCIDENT WHERE THE NURSES HAD NOT NOTICED THAT A PATIENT WAS ALARMING FOR ASYSTOLE FOR 21 SECONDS SINCE SO MANY OTHER ALARMS WERE ACTIVE AT THE SAME TIME. THE BIOMED INDICATED THAT THEY WOULD LIKE TO HAVE A DIFFERENT AND MORE SERIOUS SOUND FOR ASYSTOLI ALARMS. THE CUSTOMER FINDS IT DIFFICULT TO DISTINGUISH THE SEVERITY OF THE ALARMS WHEN SEVERAL ARE ACTIVE AT THE SAME TIME. THE PHILIPS DEVICE WAS OPERATING AS INTENDED THROUGHOUT THE INCIDENT. THERE WAS NO PRODUCT MALFUNCTION, THIS IS CONSIDERED A USER ISSUE AND AN ENHANCEMENT REQUEST. A CUSTOMER FEEDBACK ENHANCEMENT REQUEST WAS SUBMITTED BY THE RSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ASYSTOLE ALARMS ARE TOO DISCREET SINCE THE STAFF MISSED AN ALARM FOR A PATIENT WHO HAD A CARDIAC ARREST. THE CUSTOMER WANTS TO KNOW IF THE SOUND CAN BE CHANGED. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, WHERE THE PATIENT HAD A CARDIAC ARREST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYSTOLE ALARMS ARE TOO DISCREET SINCE THE STAFF MISSED AN ALARM FOR A PATIENT WHO HAD A CARDIAC ARREST. THE CUSTOMER WANTS TO KNOW IF THE SOUND CAN BE CHANGED. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, WHERE THE PATIENT HAD A CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923612 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization