BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 9069876 · Received September 16, 2019

    Report

    Report Number
    1218950-2019-07063
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Report Date
    August 26, 2019
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE AC LED LIGHT FOR THE DEVICE POWERED OFF DUE TO A FAULTY AC MODULE (API1AD41-000 C 0419 C 002658). IT WAS ALSO NOTED BY THE CUSTOMER THAT THE AC MODULE WAS MAKING A HUMMING NOISE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE PATIENT/USER IMPACT AS A RESULT OF THE ALLEGED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866405 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1