BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 11646553 · Received April 10, 2021

    Report

    Report Number
    3030677-2021-10874
    Event Type
    Malfunction
    Date Received
    April 10, 2021
    Date of Event
    March 22, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838006652
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE UNIT FAILED TO OBTAIN A 12 LEAD ECG READING. THE ALLEGED FAILURE WAS OBSERVED WHILE THE DEVICE WAS IN USE ON A PATIENT, HOWEVER, NO ADVERSE PATIENT IMPACT WAS REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543864 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1