BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 12235766 · Received July 27, 2021

    Report

    Report Number
    3030677-2021-13221
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    July 6, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Removal / Correction Number
    FCO86100201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE NO LONGER CHARGES NEEDS AC POWER MODULE. THE CUSTOMER WORKED WITH THE TECHNICAL SUPPORT REPRESENTATIVE. THE CUSTOMER CONFIRMED THAT THEY NEED HE AC POWER MODULE SINCE BATTERIES ARE NO LONGER CHARGING. UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE AC POWER MODULE, THE REPLACEMENT FOR WHICH WAS ORDERED TO THE CUSTOMER. THE CUSTOMER TO INSTALL MODULE. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE NO LONGER CHARGES NEEDS AC POWER MODULE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132760 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown