BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 11858646 · Received May 20, 2021

    Report

    Report Number
    3030677-2021-11615
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 23, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THE DEVICE DID NOT REGISTER OR PICK-UP ECG SIGNAL DURING CODE. WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY AS THIS MAY HAVE CAUSED A DELAY IN LIFE SAVING THERAPY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. MULTIPLE REQUESTS WERE MADE FOR ADDITIONAL PATIENT DETAILS, HOWEVER, NO INFORMATION WAS RECEIVED. NO ECG MONITORING STRIPS OR CASE EVENT FILES WERE PROVIDED TO PHILIPS FOR REVIEW. A PHILIPS REPAIR BENCH TECHNICIAN EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE ISSUE. NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION. BECAUSE THE PROBLEM COULD NOT BE RECREATED, THE CAUSE CANNOT BE DETERMINED.

    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 DEVICE DID NOT REGISTER OR PICK-UP ECG SIGNAL DURING CODE. ADDITIONAL DETAILS HAVE BEEN REQUESTED. WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY AS THIS MAY HAVE CAUSED A DELAY IN LIFE SAVING THERAPY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752311 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention