BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2233078 · Received July 26, 2011

    Report

    Report Number
    1218950-2011-02130
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Report Date
    June 30, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE HAS DEVICE ERROR AND SERVICE REQUIRED MESSAGES ON THE SCREEN. THE DEVICE ALSO HAS A SHOCK EQUIPMENT MALFUNCTION AND PACER EQUIPMENT MALFUNCTION ERROR MESSAGES ON THE DISPLAY. THERE WAS NO REPORTED PATIENT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THE COMPLAINT. IT WAS FOUND THAT THE DEVICE HAD CORRUPTED SOFTWARE FILES THAT NEED TO BE REPAIRED. THE CORRUPT SOFTWARE FILES WERE DELETED BY THE PHILIPS TECHNICIAN AND THE REPAIR TECH CONFIRMED THAT THE UNIT IS BACK TO NORMAL WORKING CONDITION. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS FOR PERFORMANCE ASSURANCE AND WAS SENT BACK TO THE CUSTOMER. AS OF (B)(6) 2011, THE CUSTOMER HAS NOT CALLED BACK FOR THIS DEVICE. WE ARE CONSIDERING THIS A MALFUNCTION RESULTING FROM CORRUPT SOFTWARE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HAS DEVICE ERROR AND SERVICE REQUIRED MESSAGES ON THE SCREEN. THE DEVICE ALSO HAS A SHOCK EQUIPMENT MALFUNCTION AND PACER EQUIPMENT MALFUNCTION ERROR MESSAGES ON THE DISPLAY. THERE WAS NO REPORTED PATIENT 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