BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2082916 · Received April 28, 2011

    Report

    Report Number
    1218950-2011-01163
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    March 31, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED NO DISPLAY. THE UNIT WAS EVALUATED ON SITE BY A PHILIPS FIELD SERVICE ENGINEER. IT WAS CONFIRMED THAT THE POWER PCA WAS FAULTY AND NEEDS TO BE REPLACED. A NEW PCA WAS ORDERED TO RESOLVE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO DISPLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1