BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX

    MDR report key: 2189638 · Received July 28, 2011

    Report

    Report Number
    1218950-2011-02176
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEY SAW AN 'INTERNAL MEMORY FAILURE' MESSAGE AFTER A PT EVENT. THE CUSTOMER ALSO STATED THAT THE DEVICE WAS NOT A FACTOR IN PT OUTCOME. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY SAW AN 'INTERNAL MEMORY FAILURE' MESSAGE AFTER A PT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE - ANDOVER M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1