BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 1981389 · Received January 31, 2011

    Report

    Report Number
    1218950-2011-00263
    Event Type
    Death
    Date Received
    January 31, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 3, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE. THE INVOLVED PT DIED, BUT THE CUSTOMER HAS NOT YET PROVIDED INFO AS TO THE ROLE OF THE DEVICE BEHAVIOR ON THE PT OUTCOME. AT THIS TIME, THERE HAS BEEN NO DETERMINATION AS TO WHETHER THE DEVICE WAS A FACTOR IN THE REPORTED DEATH OF THE PT. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death