BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 8723045 · Received June 21, 2019

    Report

    Report Number
    1218950-2019-04458
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Report Date
    June 28, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WAS IN NEED OF A REPLACEMENT POWER PCA. NO FURTHER DETAILS WERE PROVIDED. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT WAS GENERATED PURSUANT TO QUALITY PLAN (B)(4) - QUALITY PLAN ¿ ECR ALS SERVICE RECORD REMEDIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515243 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1