BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 18848255 · Received March 6, 2024

    Report

    Report Number
    3030677-2024-00846
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 28, 2024
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE MRX DEFIBRILLATOR INDICATING THAT THE DEVICE FAILS THE THERAPY DELIVERY TEST. THE SITE ENGINEER WORKING WITH THE RSE CONFIRMED THE DEVICE FAILS THE THERAPY DELIVERY TEST. THE DEVICE NEEDS A HIGH VOLTAGE CAPACITOR AND A THERAPY PRINTED CIRCUIT ASSEMBLY (PCA). HOWEVER, THE DEVICE IS END OF LIFE (EOL) SINCE 31 DECEMBER 2022 AND NO PARTS ARE AVAILABLE FROM PHILIPS. NO FURTHER ACTION AT THIS TIME. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM IS THE HIGH VOLTAGE CAPACITOR AND THE THERAPY PCA. THE REPORTED PROBLEM WAS CONFIRMED. THE EVALUATION INDICATES A PARTS ISSUE BUT SINCE THE DEVICE IS EOL NO PARTS FROM PHILIPS ARE AVAILABLE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165016 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown