BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 11619373 · Received April 6, 2021

    Report

    Report Number
    3030677-2021-10711
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 16, 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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS, THAT THE DEVICE WOULD NOT CHARGE THE BATTERY. THERE WAS REPORTEDLY NO PATIENT HARM. THE CUSTOMER EVALUATED THE DEVICE. AND RECEIVED REMOTE SUPPORT FROM THE CUSTOMER CARE SOLUTION CENTER, DURING WHICH A QUOTE WAS PROVIDED FOR DIAGNOSTIC SERVICE. THE CUSTOMER DECIDED TO REPLACE THE DEFIBRILLATOR. ALTHOUGH, NO EVALUATION WAS PERFORMED, THIS WILL BE DOCUMENTED AS A MALFUNCTION THAT OCCURRED, AT THE TIME OF THE REPORTED EVENT. THE CAUSE OF WHICH WAS NOT DETERMINED. THE DEVICE REMAINS AT THE CUSTOMER SITE. AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE BATTERY WILL NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE BATTERY WILL NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521326 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown