BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 12802500 · Received November 12, 2021

    Report

    Report Number
    3030677-2021-15576
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    October 19, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER EVALUATED THE DEVICE. AND RECEIVED REMOTE SUPPORT FROM THE CUSTOMER CARE SOLUTION CENTER. DURING WHICH, A QUOTE WAS PROVIDED FOR REPLACEMENT OF THE THERAPY BOARD AND/ OR CAPACITOR. UPON CONCLUSION OF THE EVALUATION. REPAIR WAS SUGGESTED TO CUSTOMER TO REPLACE THE THERAPY BOARD AND/ OR CAPACITOR. THE SERVICE MANUAL WAS SENT THROUGH SDT TO CUSTOMER. 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 DEVICE EXPERIENCED A DEFIB TEST FAILURE AND DISPLAYED A SHOCK EQUIPMENT MALFUNCTION MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702580 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown