BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 11080766 · Received December 28, 2020

    Report

    Report Number
    1218950-2020-08112
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Report Date
    December 23, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Removal / Correction Number
    Z-1923-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SERVICE ORDER WAS CREATED IN THE SOURCE SYSTEM TO HOUSE THE IMPLEMENTATION OF (B)(4) AS THE DEVICE MET THE CRITERIA NOTED WITHIN THE FCO. THE FCO PERTAINS TO A FAULTY AC POWER MODULE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539155 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1