BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3060670 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01142
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 4, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FREEZES DURING OPERATIONAL CHECK AFTER THE CHARGE BUTTON IS PRESSED. THE SHOCK BUTTON LIGHTS UP BUT NOTHING HAPPENS WHEN HE PRESSES IT. THERE WAS NO PATIENT INVOLVEMENT, THIS OCCURRED DURING TESTING. THE RESPONSE CENTER PERFORMED TROUBLE SHOOTING AND ADVISED THE CUSTOMER TO RELOAD THE SOFTWARE ON THE DEVICE TO RESOLVE THE ISSUE. THE RESPONSE CENTER FOLLOWED UP WITH THE CUSTOMER. THE CUSTOMER CONFIRMED THAT THEY RELOADED THE SOFTWARE ON THE DEVICE TO RESOLVE THE ISSUE. WE ARE CONSIDERING THIS A MALFUNCTION RESULTING FROM CORRUPT SOFTWARE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FREEZES DURING OPERATIONAL CHECK AFTER THE CHARGE BUTTON IS PRESSED. THE SHOCK BUTTON LIGHTS UP BUT NOTHING HAPPENS WHEN HE PRESSES IT. THERE WAS NO PATIENT INVOLVEMENT, THIS OCCURRED DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128935 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1