BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 10105749 · Received June 1, 2020

    Report

    Report Number
    1218950-2020-03205
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Report Date
    May 28, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Removal / Correction Number
    Z-1923-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE AC LED LIGHTS WERE NOT ILLUMINATING AND THAT THE DEVICE FAILED TO CHARGE THE INSTALLED BATTERY DUE TO A FAULTY AC MODULE (LOT NUMBER 041659). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570145 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1