BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2212822 · Received July 12, 2011

    Report

    Report Number
    1218950-2011-01960
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Report Date
    June 13, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE HAS A BROKEN DISPLAY. THERE WAS NO REPORTED PT INVOLVEMENT. A PHILIPS FSE EVALUATED THE DEVICE AND CONFIRMED THE COMPLAINT. THE FIELD SERVICE ENGINEER DETERMINED THAT THE UP AND DOWN ARROW BUTTONS HAD FAILED. THE DISPLAY ASSEMBLY WAS REPLACED TO RESOLVE THE PROBLEM. WE WILL CONSIDER THIS A MALFUNCTION OF THE DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE HAS A BROKEN DISPLAY. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1