BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 11896147 · Received May 27, 2021

    Report

    Report Number
    3030677-2021-11801
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    May 13, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT: THE CUSTOMER DECLINED SERVICE FROM PHILIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THE "HEART RHYTHM WENT BLUE". WE ARE CONSIDERING THIS TO BE A POSSIBLE CODE-BLUE SHOCK-ISSUE SITUATION POSSIBLY CAUSING A DELAY IN LIFE SAVING THERAPY, THEREFORE, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. THE CUSTOMER DID NOT RESPOND TO MULTIPLE REQUESTS FOR PATIENT/PROCEDURE DETAILS. THE CUSTOMER DID NOT RESPOND TO MULTIPLE REQUESTS FOR EVALUATION DETAILS. THE CUSTOMER DECLINED SERVICE FROM PHILIPS. NO ECG MONITORING STRIPS OR CASE EVENT FILES WERE PROVIDED TO PHILIPS FOR REVIEW. THE CUSTOMER DID NOT RESPOND TO MULTIPLE REQUESTS FOR RESOLUTION DETAILS. NO CONCLUSION CAN BE DRAWN. THE DEVICE REMAINS WITH THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THE "HEART RHYTHM WENT BLUE". ADDITIONAL DETAILS HAVE BEEN REQUESTED. WE ARE CONSIDERING THIS TO BE A POSSIBLE CODE-BLUE SHOCK-ISSUE SITUATION POSSIBLY CAUSING A DELAY IN LIFE SAVING THERAPY, THEREFORE, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793056 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R